FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 3944175
·
Received May 7, 2014
Report
- Report Number
- 9616066-2014-00462
- Event Type
- Malfunction
- Date Received
- May 7, 2014
- Date of Event
- February 1, 2014
- Report Date
- February 12, 2014
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER'S REPORT OF A SET LEAKING DUE TO CUT IN THE TUBING WAS CONFIRMED. VISUAL INSPECTION REVEALED THAT THE PVC WAS SLICED APART 6.5 INCHES BELOW THE DRIP CHAMBER. FUNCTIONAL TESTING CONFIRMED A LEAK FROM THE CUT IN THE TUBING. THE ROOT CAUSE OF THE SEVERED TUBING WAS IDENTIFIED AS A MANUFACTURING ISSUE. THE SEVERED TUBING IS CONSISTENT WITH TUBING THAT IS DAMAGED DURING THE POUCH SEALING PORTION OF THE ASSEMBLY PROCESS.
Description of Event or Problem · 1
CUSTOMER REPORTED DURING PRIMING, THE SET WAS LEAKING FROM A CUT THAT WAS JUST BELOW THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274939 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORP | 2120-0500 | 13105534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |