FDA Adverse Event
Death
Summary report: N
NONE
MDR report key: 55852
·
Received December 16, 1996
Report
- Report Number
- MW1010420
- Event Type
- Death
- Date Received
- December 16, 1996
- Date of Event
- October 6, 1994
- Report Date
- October 4, 1996
- Manufacturer
- LITTLE GIANT PUMP CO.
- Product Code
- KPF
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
ON 7/1/94, RPTR'S HUSBAND WAS TAKEN OFF OF HAND DIALYSIS AND PUT ON A DIALYSIS CYCLER AND PUMP. THESE MACHINES WERE PRESCRIBED BY HIS DRS. RPTR'S HUSBAND DIED ON 10/6/94. AFTER HIS DEATH, RPTR BEGAN GATHERING ALL MACHINES, MEDICATION AND SUPPLIES THAT WERE PRESCRIBED. RPTR DISCOVERED A GREEN SLIME SUBSTANCE IN THE PUMP. RECALLED A PERSON AT THE FACILITY SAYING SHE HAD NEVER HEARD OF A PUMP WITH A CYCLE. RPTR CALLED THE MFR OF THE PUMP AND WAS TOLD THE PUMP WAS NO MORE THAN A CONDENSATED AIR CONDITIONER PUMP AND WAS NOT TO BE USED AS A MEDICAL DEVICE AND CERTAINLY NOT TO BE USED ON PEOPLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | CONDENSATED AIR CONDITIONER AND PUMP | KPF | LITTLE GIANT PUMP CO. | VCM15ULS | 115VAC 60-HZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Death | SOLUTION WHILE DIALYSING| PUMP WAS USED WITH CYCLER FOR DRAIN USED DIALYSIS |