FDA Adverse Event
Malfunction
Summary report: N
CLEARSTAR PUMP
MDR report key: 1203434
·
Received October 15, 2008
Report
- Report Number
- 1527460-2008-00879
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 30, 2008
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- LZH
- PMA / PMN Number
- K981541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 REPORTER INDICATED THAT 300 ML OF FEEDING WERE HUNG AND THE FEEDING RATE WAS SET AT 80 ML/HR. AFTER ALMOST 4 HRS, THERE WAS APPROXIMATELY 200 ML LEFT TO BE FED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEARSTAR PUMP | LZH PUMP, INFUSION ENTERAL | LZH | ABBOTT NUTRITION | 55239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |