FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 3940238
·
Received April 7, 2014
Report
- Report Number
- 9616066-2014-00313
- Event Type
- Malfunction
- Date Received
- April 7, 2014
- Date of Event
- December 7, 2013
- Report Date
- March 17, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
CUSTOMER MEDWATCH RECEIVED, REPORTED THAT THE SET WAS FOUND TO BE LEAKING DURING A HEPARIN INFUSION. UPON INSPECTION, BIOMED FOUND THAT THE TUBING HAD A PINHOLE IN THE PUMPING SEGMENT JUST BELOW THE UPPER FITMENT. THERE WAS NO PATIENT HARM REPORTED. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205787 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 2420-0007 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PUMP MODULE: SN UNK| ALARIS PC UNIT: SN UNK |