FDA Adverse Event
Injury
Summary report: N
ENTERALITE INFINITY ENTERAL FEEDING PUMP
MDR report key: 2573897
·
Received May 7, 2012
Report
- Report Number
- 1722139-2012-00722
- Event Type
- Injury
- Date Received
- May 7, 2012
- Date of Event
- January 1, 2008
- Report Date
- October 30, 2008
- 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
THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW FOR REPORTABILITY.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE HOSPITAL PROGRAMMED A DOSE OF 300ML THAT SHOULD HAVE PASSED IN 5 HOURS, BUT THE CHILD RECEIVED 500ML IN 1 HOUR, 30 MIN.
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 |