FDA Adverse Event
Death
Summary report: N
AP II PUMP
MDR report key: 325548
·
Received April 4, 2001
Report
- Report Number
- 6000001-2001-00145
- Event Type
- Death
- Date Received
- April 4, 2001
- Date of Event
- January 30, 2001
- Report Date
- March 29, 2001
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCOUNT REPORTS POST-OP PT EXPIRED WHILE RECEIVING INFUSION OF MORPHINE VIA APII PUMP. THE REPORTER STATED THE PUMP WAS PROGRAMMED TO DELIVER A PCA DOSE OF 1ML EVERY SIX MINUTES, WITH A CONCENTRATION OF 1MG/ML. THE PT HAD BEEN RECEIVING THERAPY FOR APPROXIMATELY 11-1/2 HOURS, WHEN THE PT'S SPOUSE FOUND PT DECEASED. THE REPORTING FACILITY STATES "THE PT'S BLOOD SERUM LEVELS WERE CHECKED AND THEY WERE OKAY." THE REPORTER STATED THEY DID NOT FEEL THE PUMP MALFUNCTIONED. THE REPORTER WAS UNABLE TO PROVIDE ADD'L INFO REGARDING THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14842 | AP II PUMP | ANESTHESIA PUMPS | FRN | BAXTER HEALTHCARE (SG) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Death |