FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 2962015
·
Received January 23, 2013
Report
- Report Number
- 9616066-2013-00039
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Report Date
- January 3, 2013
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER STATED THAT THE PRODUCT WOULD NOT BE RETURNED. THE CUSTOMER'S REPORT THAT THE VALVE BROKE OFF COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVAL. THE ROOT CAUSE WAS NOT IDENTIFIED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VALVE BROKE OFF (INTO THE LUER TOP) WHEN THE SECONDARY TUBING WAS ATTACHED TO THE PRIMARY SET. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33270 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORP. | 2426-0007 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | SWABCAP: MFR, MODEL, AND LOT# UNK |