FDA Adverse Event
Malfunction
Summary report: N
ENTERALITE INFINITY ENTERAL FEEDING PUMP
MDR report key: 3850828
·
Received March 21, 2014
Report
- Report Number
- 1722139-2014-00066
- Event Type
- Malfunction
- Date Received
- March 21, 2014
- Date of Event
- February 12, 2014
- Report Date
- February 26, 2014
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PUMP HAS BEEN TESTED SEVERAL TIMES USING WATER, AND EACH TIME WHEN BAG WAS EMPTY PUMP STOPPED PUMPING AND ALARMING NO FOOD (OR PUMP FINISH DOSE: ALARMING "DOSE DONE"). ALL ALARMS HAVE BEEN CHECKED AND WORK PROPERLY. COMPLAINT COULD NOT BE DUPLICATED.
Description of Event or Problem · 1
CUSTOMER STATED THAT THE PUMP IS RUNNING AFTER THE BAG IS EMPTY. RATE AND DOSAGE PROVIDED ARE 37 ML/HR AND 360 ML. THERE WAS NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170471 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | LZH | MOOG MEDICAL DEVICES GROUP | SMALL VOLUME INFINI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 MO |