FDA Adverse Event
Malfunction
Summary report: N
FLEXIFLO COMPANION ENTERAL NUTRITION PUMP
MDR report key: 200856
·
Received December 3, 1998
Report
- Report Number
- 1528738-1998-00066
- Event Type
- Malfunction
- Date Received
- December 3, 1998
- Date of Event
- November 8, 1998
- Report Date
- November 9, 1998
- Manufacturer
- ROSS PRODUCTS DIV ABBOTT LABORATORIES
- Product Code
- LZH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
THE PT WAS BEING FED IN THE HOME AT NIGHT USING A PUMP. 20 FL OZ OF A HOME-MIXED ENTERAL FEEDING SOLUTION WERE HUNG. THE PUMP SHOWED 100 CC FED, BUT THE FEEDING CONTAINER SHOWED 200 CC HAD BEEN FED. THE PUMP DID NOT ALARM. THE REPORTED STATED TWO PUMPS AND MANY DIFFERENT PUMP SETS HAVE YIELDED THE SAME PROBLEM, BUT ONLY PROVIDED DETAILS OF THIS ONE EVENT. FOLLOWING THE EVENT, THE PT VOMITTED. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT. ONE PT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXIFLO COMPANION ENTERAL NUTRITION PUMP | 80 LZH PUMP, INFUSION, ENTERAL, EXTERNAL | LZH | ROSS PRODUCTS DIV ABBOTT LABORATORIES | 84 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 MO | Other |