FDA Adverse Event
Malfunction
Summary report: N
LZH PUMP, INFUSION, ENTERAL
MDR report key: 1195909
·
Received October 9, 2008
Report
- Report Number
- 1527460-2008-00864
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 10, 2008
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- LZH
- PMA / PMN Number
- K981541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REPORTED IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE THAT IS MARKETED DOMESTICALLY.
Description of Event or Problem · 1
THE COMPLAINANT REPORTS AN UNDER DELIVERY. THE PUMP WORKED PROPERLY THE FIRST DAY. ON THE SECOND AND THIRD DAY, IT DID NOT WORK AND NEARLY ALL THE NUTRITIONAL PRODUCT REMAINED IN THE FEEDING CONTAINER. THE FOLLOWING DAY, THE PUMP WAS USED AGAIN AND IT WORKED PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LZH PUMP, INFUSION, ENTERAL | CLEARSTAR PUMP | LZH | ABBOTT NUTRITION | 55239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |