FDA Adverse Event
Death
Summary report: N
CVP CATHETER 3 LUMEN EXPANDED KIT
MDR report key: 10254
·
Received September 30, 1993
Report
- Report Number
- 10254
- Event Type
- Death
- Date Received
- September 30, 1993
- Date of Event
- September 23, 1993
- Report Date
- September 27, 1993
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT ADMITTED 9/12/93 FOR SBO. TO OR 9/12/93 AT 1:00, FOR EXPLORATORY LAP WITH RELEASE OF SBO. PT TAKEN BACK TO SURGERY 9/21/93 AT 1450 FOR SBO WITH PERSISTENT OBSTRUCTION. OPERATION PERFORMED: EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, RESECTION OF TERMINAL ILEUM AND PROXIMOL RIGHT COLON WITH ILEOSTOMY (PT HAD INSERTION OF INTERNAL JUGULAR TRIPLE LUMEN LINE AT THIS TIME ALSO). ON 9/23/93, THE PT CODED AND EXPIRED. AUTOPSY REVEALED CAUSE OF DEATH AS PERICARDIAL TAMPONADE DUE TO PERFORATION OF RIGHT ATRIUM DUE TO CENTRAL VENOUS LINE PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVP CATHETER 3 LUMEN EXPANDED KIT | CENTRAL VENOUS CATHETER 20 CM 7 FR | DQO | ABBOTT LABORATORIES | 41401-04-01 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Death |