FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 2942045
·
Received December 26, 2012
Report
- Report Number
- 9616066-2012-00922
- Event Type
- Malfunction
- Date Received
- December 26, 2012
- Report Date
- December 6, 2012
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE SET BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
CUSTOMER REPORTED IV TUBING LEAKING AT THE UPPER SILICONE SEGMENT. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORP | 2420-0007 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE, SN UNK |