FDA Adverse Event
Malfunction
Summary report: N
ENTERALITE INFINITY ENTERAL FEEDING PUMP
MDR report key: 2961490
·
Received January 17, 2013
Report
- Report Number
- 1722139-2013-00102
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K031199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FOUND THAT PUMP WAS TESTED FOR ACCURACY SEVERAL TIMES, USING WATER. PUMP DELIVERED AMOUNT WITHIN SPEC (SPEC IS +/- 5%). COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
CUSTOMER STATES THAT PUMP DELIVERS 2/3 OF DOSE INSTEAD OF 3420 ML. RATE AND DOSE PROVIDED ARE 19 ML/HR AND 3420 ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27110 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | LZH | MOOG MEDICAL DEVICES GROUP | INFINITY PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | PEPTEMIN |