FDA Adverse Event
Malfunction
Summary report: N
FLEXIFLO PATROL ENTERAL PUMP
MDR report key: 501220
·
Received December 1, 2003
Report
- Report Number
- 1528738-2003-00039
- Event Type
- Malfunction
- Date Received
- December 1, 2003
- Date of Event
- October 23, 2003
- Report Date
- October 27, 2003
- Manufacturer
- ROSS PRODUCTS DIVISION, ABBOTT LABORATORIES
- Product Code
- LZH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT WAS BEING FED USING A PUMP. NINETY ML OF AN ENTERAL FEEDING SOLUTION WERE HUNG, AND THE PUMP WAS SET TO DELIVER 22 ML/HR. NINETY ML WERE DELIVERED IN 1 HOUR. FOLLOWING THE EVENT, THE PT DEVELOPED ABDOMINAL DISTENTION AND WAS KEPT NPO AND OBSERVED FOR SEVERAL HOURS. PHYSICAL EVALUATION PERFORMED. ENTERAL FEEDING WAS RESUMED. 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 PATROL ENTERAL PUMP | 90 LZH PUMP, INFUSION, ENTERAL, EXTERNAL | LZH | ROSS PRODUCTS DIVISION, ABBOTT LABORATORIES | 52036 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO | Other |