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ヒヤリロハット事例等収集結果 ― 医療機器 ―

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Contents

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9. No 1
10. X
11. gt gt
12. 1 32 61
13. 9
14. 1 14
15. 1 2 3
16. 22 1 1 2
17. 1 10mL 1QmL 10mL
18. 1 Ci
19. X
20. 2 3 1 16 61 a NR Pp s VSD
21. ME 14 61
22. 1 3 3 4
23. 3
24. o 9 4
25. CT 27 61
26. 6 9
27. CV MD 90990 MD 90890 MD 90991 MD 90891 MD 90892 2012 1 ww No 1113001000 30 31 9 0 3 G3 4 J t2007 11 21 6 2006 10 2 160008ZZ00787 51 JMDN 35084114 JWN 35094103
28. CHDF 1 3 40 SIRS ICU
29. 1 CT
30. 6 41
31. 3 6 30cm loo
32. 6 TPS CORE 132C 134 1 0
33. 5 2008 02 30 1 20
34. IABP ICU ME bronchofbe A B 1 A 1 2
35. CV o 1
36. 49 61 3 EY BFF cy
37. 2 2 2 2 1 2 3
38. 38 9C 35 61 CVC lt CVC A CVC
39. 1
40. 1 1 2 2 1 2
41. X X 1
42. p rasA Pe TEL 03 3506 9486 spa mala iii FAX 03 3506 9543 http wwwinfopmda goip 3 3 2 2 1 Pd NN K 0 I LW 4 2 gt gt gt 3 1 4
43. Proxigai Sca Medial Distal Ocm 1W 581 0067
44. 55 61 00 Ak Hi 2 1W 1 ES 3 PLT1 5 3 CVv Pb
45. 1 CV
46. 2 2012 09 10 5
47. N G a NG 5
48. 57 61 MCA
49. http Avwwjiamdi org anzen index html 2 3 PMDA No 15 2010 3 http wwwjnfopmda_gojp 1096
50. 2 2 7 2 C 1 BB 3 1
51. 1 I1V 1 1 4 2 CV
52. k gt gt wt gt 5um 90 1 2
53. 2 oeo INE P1 3 P4 10 P11 18 P19 31
54. 5 SpO2 40 5 6 16 SpO2 7 SpO2 AO 10 61
55. 1 2 2 2 2 3 1 3
56. SPO2 SPO2 58 10 2 3 26 PCPS 0 0 PCPS PCPS o
57. PTPE 4 1W 8 5 gt 6
58. CVC ICU CVC 90 mmHg 60 mmHe FFP CVC CVC 60 mmHg 110 mmHg CVC 15 ICU 9
59. 2
60. 1 3 2 A 1 D B 2
61. S 29 6 7r MR Ca Me
62. SpO2 1 3 9 0 909 6 40
63. 2 20 35 3 20 40 4 5 20 45 SPO2 9796 9200 116 54mmHg 130 SPO2 97 989 7 21 28 2 16 18 8 21 30
64. 100 200 14
65. 8 61 50ml 10 4
66. ICU 45 61 2 4m h 1 6O 100 10 O 24
67. X ARDS ICU ml 5 50 1 2 1
68. 1 O
69. 2 No 1113001000 22 24 X
70. CV o
71. ICU 3 61 CV 2 oe om me FOLFIRI5 11 20 XP 12 45
72. 13 50 4 13 40 13 45 13 48 4cm 8cm 1cm 15 00
73. 2 1 2 1 Oml Omi 2
74. ptt at ON 0 1 ON AC
75. 2 D 1 2 9 61 0 EI EPJ 1 17 30 eet 2 2 2
76. 24 2011 5 27 12 2010 12 1 11 2 5 1 21800BZZ10076000 74 JMDN 70384000 IV 1 X 1 1 Ma
77. 3 136 4 1 1 2 3 AED
78. SpO2 8096 9 09 SpO2 11 20 26cmH2O 13 8 f
79. 2 19 4 42 61 5 1 1
80. TW W 3 7 1
81. NG 1 34 N G 26 61
82. 13 00 13 35 14 05 CV CT CV 7
83. 67 8 34 61 133 i 1 BMI36 OE
84. 104mmHg HR 132 38 CPAP FiQ2 459 6 PEEP 7cmH2O PS 20cmH2O 4 lt 5 84mmHg HR 90 Paf SAT 3 5 SIMV FiO2 7096 20 Pinsp 28cmH2O Tinsp 1 2cmH2O PEEP 6cmH2 O PS 20cmH2O PE HP
85. 0 25mL 61 61 A 1 ea 0
86. 1 61 3 dee GUI 5 ly ep EE PMDA No 15 2
87. 2 3 2 Dr 10 A ECG ABP PAP CVP SpO2 SpO2
88. 59 61 1
89. 5 30ml 5 18Fr 1 60 ASO ASO 3
90. 19 61 30 ui bt
91. 5 10 00 6 10 05 8Fr 625ml PPT A dae re 3 H b4 8g dl Ht13 9 CT 1000ml 22608s 30 61
92. 8396 0 59 B 0 59 3 R 1 6 eh 2 0 5
93. OFF GE OFF 8 30 1 10 6 61
94. IA B A X eS B B C PCPS
95. 8 72 99 4
96. 5mm 4cm 5 CT 5 3 faa o CT CT 5 OT
97. 8L SPO2 97 37 61 a oe mm Te 5 5 a 3 2
98. 2 3 4 Bp140 2 1 2 2 o 3 4
99. X 2 3 4
100. X 25 lt gt 1 2 lt gt 1
101. CT 8 8 0 2 15
102. AC 9 om rh h Rp 3mm 1 8 58
103. 9 2 amp 5 72
104. CV f ia CV CV
105. 2 2 3 4 12 X P ED L
106. 2 53 61 co em mm Em PNDYS PR A 4 ET
107. PCPS lt 2 3 o 51 61 BE tt 21
108. 3 4 in vilro OR 1608 2 15 6mm in vitro AE pls LM 5 TN A 27 8 38 1 B 29 3 34 0 6
109. 2 60 61 RD mag V JMS SPg 8722 500D O 3A N 40 A 2cc
110. TE 1 1 1 1 1 Mr
111. 1 3 13 1 23 5D 4 W 13 5D W 1 4
112. 2 1 CT RDS 1 PTCD
113. X CVC 1 13 00 B X Y SpO2 99 X Y
114. ee 16 10 10Fr 3 er 3 14 EFT 6 4 14 17 35 SPO2 10L 18 00 CT CT 18 30
115. lt x 28 61 a ae el Fe 1 Yt rit RE 2 X X
116. 10nL 10mL ve 28 1 1 2 3 4 9 9 1 11 13 14 6 X
117. A Ndi 3 Tl1 1 23 5D 23 5D 2 2
118. SPO258 0 35 SPO2 1 23 50 HR12O 130 SPO298
119. X P 1 10cm X P X P 2 15 X P 50ml100ml 10cm
120. 2 10mL lt gt Huber Pont Neede DMSO
121. 3 3 18 05 3 1 4 4 18 10 4
122. CVP 4 99 5 9 6 D 7 09 8 Gm WO 0 Gsm 9
123. 10 15 8cm 1 1
124. 6 BIPAP 1 BIPAP 1 30 4 BIPAP 7 HR50 SPO2 SPO2 BIPAP 8 BIPAP id N 9 BIPAP DNR BIPAP
125. 1 1 1 2 12 lt 30 3 21 3 4 10 15 4 22 30 16 40 i EE
126. 58 61 ICU 1
127. 2 CV C BT ADL 25GQ 3PI 8 SPO2859
128. CV IV 3 2 1mm 10cm CV CV IV
129. 5 7 13 41 J vacDrain 8 14 20 Hb10 5 9 15 42 1705ml 10 16 10 Bp141 54mmhg P93 SPO2 98 ICU 11 OP Hb14 9 OP Hb10 6 Hb11 1 52 61 Ee EE
130. 15 61 2
131. 3 12 55 16 35 A SSI 12 R 05 R 0 5 0 59 1 8396 2 R 0 5
132. URL http www info pmda go jp info idx push htm1 TEL 03 5253 1111 2751 2758 21 0525 2 0525 2 2 3 5 25 1
133. B IA lt 60mm
134. 3 1 2 4 1 3 23 6 24 5 6 23 1 Cook Japan
135. CV X3820HSJD CV X3820HSJD 23 12 1 2 67 16 17 2 2 Edwards 2 4 0525 1 0525 1 2 3 5 2 5
136. 80 1
137. 1 56 61 HuJ o F gt ICU 1 11 2 6 Se AO 1 1 1
138. PTBD 44 61 EE eee am ee ICU ER ET ICU 12 55
139. gt X UT Ti eS
140. ISE 1SEg 1SE 72 1 1 Amplatz K A Simple Non Thrombogenic Coating Invesr Radtoit 6 4 280 289 1971 2 Chastre J et al Throwbosis as eComplicatlion of Pulmonary Artery Catheterization via the Inter
141. wire 54 61 i 8 ts 1 2 3 1
142. 5mg 21 20 2 40cm CT 43 61 HPIc mi ws mw ww NA Ah De JV
143. CR S 1 6 12010 4
144. 1 GL Huber
145. ISonoSurg 2 3 15 00 5 1 5 4 3mm 5 SonoSurg ra 2 lt
146. P32 33 4 BE PMDA No 15 2010 3 http wwwinfopmda_goJp 1096 1096 0 59 9 109
147. ME IME 10 2 48 61 o
148. 1 12 13 16 17 18 19 21 Ge OO PIT TF CE TI DI TOTTIN ATCIIE CEC HEIL TT FO WM EY bBH 6 BGLY 1 X
149. 2 3 13 14 2 21 30 1 23
150. PCI 10 2 1
151. k CT 17 CT 20
152. 5 9 0 CV 5 CVv 9 50 10 50 CV
153. 4 R 0 5 RY GIII 4 CM 5 5 i IAED VFI Vf AED AED MRI
154. NPPV 49 74 296 NIPPV LAN NPPV 218 o PK 2L 10
155. gt 172 32
156. 1 Y 2 2 Rs 9 40
157. 30 12250mL 8 4 12 61
158. 150ml 3 ICU 2 5 PTBD
159. 2 2 GIA30 3 13 38 2 GIA30 AN 4 ec 5 13 39 GIA3 0 6 13 39 4 0 1
160. 2 3 2 5 959 1
161. 5cm jgA B
162. MS Co CV IM SpO28096 4 500m 1 5
163. C 28 6 34 0 072 925 6548 7 1 2 3 4 5 6
164. nh a 1 LT 7 40 2 0 2 ME 1 2 13 2 ME
165. 1 20 18 61 RE o 5Ocm x 80cm CV cCV 11 17
166. 12 43 ACT136 7cm 12 46 ACT116 ACT 12 58 ACT249 16 47 CV 16 48 CVC 17 48 CV 12G 20cm 18 10 CU SIMV 4096 BP117 65 HR84 Hb10 2 18 45 CT
167. SPO2 12 1 4 SPO2 3 5 ee SPO2 6 6 4 BiPAP 4 1 ICU 3 OFF 1 596
168. 2 3 CO2 0 20 61 EEE cm mw yh Siti a 1cm ETCO2 ICU VM
169. Dr 40 61 0 Om mm Tm 0
170. 3 6 5 OO tg 2 ME i A CVC
171. lm Yitro in vitro in vivo im vivo 1 2 3 1 2 3 25G 3mL
172. 2 100mL SP 02 5 30 11
173. CVC 3 2 36 61 2 2 25G PI 3 pI 27G 3PI 27G 4 46 5 7cm 6 7
174. 3 4
175. 3 A 1 O A 3 VT 4 30 A CPR 14 CCU QRS
176. 4 No 1113001000 10m lt
177. MRI AED VF AED VF AED 2
178. N G NG 6 20ml NG 9
179. Ga 5 O
180. ee OP A A Ns 9 3 ICU 1
181. B B 1 C A 2 B B A 2 1 2 1
182. CV CV 6 CV ICV
183. 1 1 27 28 23 7 1 12 31 2 23 7 1 12 31 3 2
184. 2 X 10mL 3cm
185. 3 3 4 34 789 41 0 22 19 3 1 3 1 ICD PC4 2 16 gt 209 8 BIPAP2 CPAP1 11 61 4 4 2
186. 1 1 30 270mg 2 20 1 5ml 1 20 1
187. 15KEL 15N 15N 4N 1 2 0M 2 3 4 5 6 in vitro in vitro
188. CHF NO low dose FP 5 FU 5 FU 1250mg 15ml 1
189. CNS ICU CT HCU High care unit CV 3 0 4 y CV CV 2 2 17 61 a moe To B 8
190. 0 22 1 2 dose FP 0 5ml hr 5ml hr 1 46 61
191. 2 1 5mL 1 2 Sal 5mL 9 TT 5aL 2dmL 5ml
192. 1 10 3 3
193. 3 X X
194. 1 9 5 0 5 5 2 3cm 1
195. 15 38 61 RD 3 4 ea 15 40 1 18 19
196. B CO2 SpO2 DI 2 C 7 61 3
197. ESP _ PICC 6 2 lt 10 CT at es o
198. 13 35 SPO2 4 SPO2 6296 5 24 6 13 40 10L SPO2 679 13 45 SPO2 8596 13 50 SPO2 88 X 13 57 SPO2 979 14 20 X 52
199. 200ml 200mi 18 18 45 90 959 6 12Fr 10Fr 779 95 2 1 7 40
200. 47 61 ae 840 2 3 2 3
201. 10cg 20cm 1cm 15cm 7 8 9 X 10 11
202. 2 A 2 gt 3mm o POI 1 2 1 0mm PCPS IABP
203. 5 Hi Vac 138C 134 ETO 100 49 57C 1 RE 2 2012 09 10 6 2 2 3 stryker 112 0004 26 1 Ve jp Japan No VS12 09 01 2012 9
204. 09 5 ee
205. 1 Om1 Oml 2 0 3 1 2 4 1
206. 4 X 5 X 6 1 2 3 1
207. 2 3 X 1 5 22G
208. 9 12 40cm 7 1 5 B B C BR
209. 9 02 2 PT 9 08 RS 9 23 CV 2 8 5Fr 14cm 10 09 10 11 3 12 01 CV 2011 11 3
210. 1 3 5 2 44 1 0120 128195 D TERUMO RG_100008ZZ00787_503_06 2 2 TERUMO
211. 2 1 1 No_I113001000 2 5 2 2012 2 140 0002 5 8 TL_03 5462 4924 i pe 240 0025 Re 179 TEL 045 710 157 Orca CV Kit IV
212. 80 AS 5 BIPAP 6 er 7 ICU ICU 8 BIPAP 50 61 OS SpO2 4mm CO2
213. 3 Tk X wv 4 to 1 9 X gt 3 9
214. 1096 196 L 8 RR Ne RM PMDA
215. 10cm 1 100ml 1 50ml 3 175ml X P
216. 3cm 3
217. 4 61 3 23 5 125 0525 1 CV IO525 1 CV 1 23 5 25 0525 1
218. 8 5 61 BiPAP 7100 3 1 BiPAP 1 BiPAP Y 2 2 Y 3 BiPAP
219. CV 5 CV CV VG CV 20 15 CV
220. 12 55 18mm XP 2 8mm 9 00 0 30 1 2 3
221. PCPS X P X PCPS 13 CT PCPS 5 0 A B C CVC
222. 13 BIPAP SPO 4 BIPAP 13 BIPAP 2459 BiPAP 98 8 5 9 40
223. Cleaning amp Sterilization TPS CORE 5100 015 250 OR_5100 004 5400 050 000 CORE p gt OR 5100 010 050 5400 034 000 OR 5100 008 OR S100 050 5400 015 000 TPS OR 5100 009 1 1
224. 1 5cm SpO2 999 8596 Sp02 SpO240 Sp02 1009 SpO2 0 22 61 23 40 3 sisi
225. 1 2 3 25 AAI P 1 QRS QRS 3 25 VT110 115 min 1OD 120 3 38 QRS AAI P 2 AAI P
226. 2 24 61 Re 133 Wm mmm 24 ie 2 12 SPO2 99 3 2
227. 3 to ne a 4 1 8cm 1 5 50 1 4 0 11 2 6 4 5 2 3 2 3 4 5 3 AA 21 61
228. HE 9 3 ED Amt E75 eAmm eH FY 5 luc N a 6 aa 1 220 200D 0794MP he 0 Le mm Cibath 2 No 1113001000 26
229. 1 11 1 2 11 SPO2 B 8m 2 92 939
230. 2 3 2
231. 29 61 1 2 3 9 00 2 9 30 3 4 9 30
232. ICV ICV CV 1 5cm 4 5cm
233. 2 27 23 12 21 28 24 22 1 P 1 2 P 6 a P 6 00 P 47 3 P 48 24 8 31 24 1
234. 2 KK 2 2 3 3 5 lo 39 61
235. 2 24 1 10 1 6 11 LED 2 32338000 70204010 7
236. 7 2 50 100ml 2 Spo2 2 1 9 30 SPO2 80 2L 18 3 9 2 3 7 30 200ml
237. 3 4 5 5cm gt SES NR 1 Y
238. 3 1 2 1 3 3 4 3 1 2
239. 4 ESD
240. 2 14 45 CV 15 50 CV CV
241. 8 1 4 5 6 6 2 1 7 Ns 2 SPA AA 23 61 0 E RUSH eee to LN i
242. X C D D 13 30 X BP85 56mmHg P125 SpO2 98 lt 9996 O2 2L min 30 18 00 100mmHg X Hb 2 0 9 3 7 3 LR4 33 61 mm 6 14 25
243. mm gt BIPAP 22 30 BIPAP 1 BIPAP BIPAP 6 3 12 BIPAP 1 12 BIPAP
244. 0525 1 CV CV CV 2012 2 NI
245. M gt gt X X
246. 3 23 6 24 5 6 20
247. 61 1 1
248. ECG 4 5 6 7 8 9 10 11 12 2 3 MC A 1 840 8
249. 1 2012 6 12 1 218008ZZ10117 51 16615200 SN 2 CV 20 ON 20 OFF 5 Ot Es EC Ee TI A 100 2
250. 18 43 100 ES A 2000 1 OT O00 30 AA 0 500 2660 500 A A
251. of Vascular Comp icatibns Cansed by Central Yenous Catheters Ciin Monit 4 4 267 271 1033 14 Laster J and D Silver Heparin Coated Cetheters and Heparin Induced Thrombocytopenia J Vasc Surg 7 067 072 1988 15 Maschke S and H Rogove Cardiac Tanponade Associated with a Multilumen Central Venous Catheter Crit Care Med 12 611 613 1984 18 Nurray I P Complications of Invasive MOnitoring ed Instrumentation 15 2 85 89 1081 17 Peter amp J L Carreat Problems inCentral Yenons Catheter Systems Inensive Care Med B 205 208 1982 18 Putterwan C Central YenonsCatheterlsation Indications TechniGnes Compllcatlons Managenent Acute Care 12 3 4 219 284 1986 19 Puri vV K et a Complications of Vascular Catheterization in the Critically Ill Cr Care Med 8 9 495 499 1980 20 Bivers H et al Central Venans Oxygen Saturation Monitoring ia he Critically Ill patient Critical Care 2001 7 204 211 2L kivers E et al Early Goal Directed Therapy In the Treataent of Severe Sepsis and Septic Shock WE7A 2001 345 19 1368 77 22 Sise M J Complications of the Flow Directed Panlmonary Artery Catheter A Prospective Analysis 1n 219 Patients Crit Care Med 9 315 318 1981 33 Schwarts Fulton J etai Sepsis Related to Intravenous and Hyperallmentation Catheters A Summary of Recent Research Findings AM 74 4 243 255 1981 24 Tullio J Heparin Lock ar Continuous F
252. 0194000 12745002 30889000 13029001 35094114 13910000 95130002 70326000 32172011 15735000 16449000 13700000 13695000 34655000 70444000 11025000 12726020 10861002 35070002 31659200 1 300kPa 2 15N 4 NBLE
253. 1 45 2 2 2 61 57
254. 113001000 1 1 yl 5Ocm PVP 2 ey 3 2 2 73 E
255. 3 25 61 0 E oe ee me we ee ME bod CE le he 30 10 A 30 1 10
256. low ro 4 5 120 136 1980 25 Arnone M Central Venous Catheter Imsertion Assst im 44CCM Procedure Manmual for Crincal Care edition Lynn McHale Dj CerlsonKK eds 8B Saunders phliadeiphtm pgs 514 521 2001 26 Yenns 8 and Mallory L Vascular Cannuiatlom in Critical Care 2nd edition Civetta JL Kirby RR Taylor RY eds I B Lippincott Philadelphia pgs 149 166 1992 2 3 2 3 Yec 180 0023 6 10 1 03 6894 0500 Edwards 23 12 160 0028 6 10 1 03 6894 0500 Edwards Llfesciences LLC VCC CV X3820HSJD 3
257. nal Juguiar Yeln N Eng J Med 306 5 278 281 1982 3 Conahan T J et el Percutaneous Catheter Introduction The Seldinger Technique JAMA 237 440 447 1977 4Cook J D et el Erroneous Electrolyte Resalts Caused by Catheters Letter to the Edilor Clin Chem 54 1 211 1688 5S Csanky Treels Ff C Hazards of Centra Venous Pressure Monitoring Anesthesia 33 172 177 1078 bElliott C G et al Couplications of Pulmonary 5 6 15 Artery Catheterlzation jn the Care of the Criticaliy Ili Patient Chest 76 6 647 653 1979 Edwards H and T C King Cardjac Tawponade frog Centre Venous Catheters Arch Surg 117 065 967 1982 B amp Greene J F et al Septic Bndocarditisg and Indwelling Pulmonary Artery Catheters J4MA4 233 8 891 892 1975 9 oiden Aberrant Locations and Complications in Initial Plmcement of Subclavian Yein Catheters Arch Sg 119 3 203 205 1984 10 ibertl T J et al Hydrothorar as a Compllcaiion of Centr amp Venous Indwelling Catheters Surg 04 5 842 846 1983 li Jacobi J et al Loss of Nitroglycerin to Central Yenous Pressare Catheter Drug Intell Clin Pharm 16 331 382 1982 12 Jarred M M et sal The Effects of Antibiotic Ointments and Antiseptics on the Skin Flora Henesth Subclsvian CutheterDressings During Intravencus Hyperallmentatlon 7 Suwg Res 22 5 521 526 1977 13 Kapadis C B et al Delayed Recognition

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