FDA Adverse Event
Malfunction
Summary report: N
LIFECARE PUMP MODEL 4P W/IO
MDR report key: 155147
·
Received February 27, 1998
Report
- Report Number
- 2921482-1998-00016
- Event Type
- Malfunction
- Date Received
- February 27, 1998
- Date of Event
- January 27, 1998
- Report Date
- January 28, 1998
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ORIGINAL REPORT FROM CUSTOMER WAS THAT THE DEVICE WOULD BE RETURNED FOR THESTING AND INVESTIGATION. THE DEVICE HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
UNDERDELIVERY REPORTED. THE PUMP WAS SET TO INFUSE 1300ML OF A FOSCARNET SOLUTION AT 750ML/HR IN THE HOME SETTING. AFTER APPROXIMATELY 2 HOURS, THE PUMP ALARMED FOR DOSE COMPLETE AND THE DISPLAY INDICATED DELIVERY OF 1300ML. THE IV CONTAINER, HOWEVER, STILL HAD APPROXIMATELY 750ML OF SOLUTION REMAINING. THE INFUSION WAS COMPLETED BY GRAVITY DRIP. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFECARE PUMP MODEL 4P W/IO | INFUSION PUMP | FRN | ABBOTT LABORATORIES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |