FDA Adverse Event
Malfunction
Summary report: N
CLEARSTAR PUMP
MDR report key: 1203429
·
Received October 15, 2008
Report
- Report Number
- 1527460-2008-00877
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- September 12, 2008
- Report Date
- September 16, 2008
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- LZH
- PMA / PMN Number
- K981541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
COMPLAINANT REPORTED THAT 250 ML WAS HUNG WITH A FEEDING SET RATE OF 120 ML/HR. THE INTENDED DELIVERY AMOUNT WAS 110 ML OVER 50 MINUTES. HOWEVER, ONE ENTIRE FEED WAS MISSED.
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 | UNK |