FDA Adverse Event
Death
Summary report: N
PHARMACIA DELTEC
MDR report key: 44892
·
Received September 17, 1996
Report
- Report Number
- 56466-1996-00001
- Event Type
- Death
- Date Received
- September 17, 1996
- Date of Event
- August 24, 1996
- Report Date
- September 16, 1996
- Manufacturer
- PHARMACIA DELTEC, INC.
- Product Code
- FRN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT WAS ON A CONTINUOUS INFUSION OF "FLORAN" PER INFUSION PUMP. PUMP AND SUPPLIES PROVIDED BY ONE PROVIDER. A DIFFERENT PROVIDER DISPENSED DRUG. THE CASSETTE WAS NOT COMPLETELY CONNECTED TO THE PUMP. PT BECAME SEVERELY SYMPTOMATIC BEFORE HUSBAND DISCOVERED THE PROBLEM. PT WAS HOSPITALIZED IN ICU. PT WAS IMPROVING FROM CRISIS WHEN SHE BECAME COMATOSE (9/7/96). PT DIED 9/8/96.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHARMACIA DELTEC | CADD I | FRN | PHARMACIA DELTEC, INC. | 5100 HFX | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Death| H |