FDA Adverse Event
Malfunction
Summary report: N
ENTERALITE INFINITY ENTERAL FEEDING PUMP
MDR report key: 2860445
·
Received November 5, 2012
Report
- Report Number
- 1722139-2012-01125
- Event Type
- Malfunction
- Date Received
- November 5, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 3, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K031199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FOUND THAT PUMP DELIVERED FOOD. COMPLAINT COULD NOT BE CONFIRMED. ADDITIONAL FOUND THAT THE SCREW BOSS THAT SUPPORT THE NON-ADJUSTMENT SIDE OF THE UPSTREAM OCCLUSION SENSOR HAS BEEN BROKEN. TOP HOUSING HAS BEEN REPLACED, PUMP CALIBRATED AND TESTED. ALL TESTS PASSES. ALL ALARMS HAVE BEEN CHECKED AND WORKED PROPERLY (NO FLOW IN, NO FLOW OUT, LOAD SET, NO FOOD AND SHUT DOOR ALARM). ALARM DOSE DONE WORKS CORRECTLY.
Description of Event or Problem · 1
CUSTOMER STATES THAT CAN HEAR THE MOTOR TURNING BUT THE PUMP DOESN'T PUMP ANYTHING OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | LZH | MOOG MEDICAL DEVICES GROUP | INFINITY PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | GEVITY |