FDA Adverse Event
Injury
Summary report: N
ENTERALITE INFINITY ENTERAL FEEDING PUMP
MDR report key: 2479004
·
Received February 22, 2012
Report
- Report Number
- 1722139-2012-00142
- Event Type
- Injury
- Date Received
- February 22, 2012
- Date of Event
- January 10, 2012
- Report Date
- January 28, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K031199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PUMP LOG SHOWS TWO OCCLUSIONS WITH ALARMS. THERE IS NO EVIDENCE FROM THE LOG THAT THE SET WAS REMOVED FROM THE PUMP TO CLEAR EITHER OCCLUSION BEFORE ANOTHER THERAPY WAS STARTED. FAILURE TO CLEAR THE OCCLUSION RESULTED IN THE PUMP INDICATING VOLUME WAS BEING DELIVERED WHEN IT DID NOT, DUE TO THE OCCLUSION.
Description of Event or Problem · 1
DISTRIBUTOR ALLEGED THEY RECEIVED A COMPLAINT THAT A CHILD WITH A MITOCHONDRIAL DISEASE WAS HOSPITALIZED FOR HYPOGLYCEMIA. THE PUMP HAD INDICATED A FEEDING OF 461ML BUT NOTHING WAS DELIVERED.
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 | Hospitalization |