FDA Adverse Event
Malfunction
Summary report: N
CLEARSTAR PUMP
MDR report key: 2191102
·
Received July 25, 2011
Report
- Report Number
- 1527460-2011-00051
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 27, 2011
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- LZH
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE REPORTED, LIT# M771, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SMALL TO A DEVICE, LIST# (B)(4), THAT IS MARKETED DOMESTICALLY.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE PT WAS TO RECEIVE 115 ML OF ABBOTT NUTRITIONAL FEED. THE PUMP WAS SET AT 150 ML/HR. AT THIS RATE, THE FEEDING SHOULD HAVE INFUSED IN 46 MINUTES; HOWEVER, THE FEEDING TOOK TWO HOURS TO COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEARSTAR PUMP | LZH, PUMP, INFUSION, ENTERAL | LZH | ABBOTT NUTRITION | M771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |