FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 2251724
·
Received August 31, 2011
Report
- Report Number
- 9616066-2011-00525
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Date of Event
- August 13, 2011
- Report Date
- August 22, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CUSTOMER STATED THAT THE SET WILL BE RETURNED, UPS LABEL PROVIDED FOR PRODUCT RETURN. ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN REC'D FOR INVESTIGATION. A F/U REPORT WILL BE SUBMITTED ONCE THE AFFECTED DEVICE HAS BEEN REC'D AND AN INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
NURSE STARTED A SECONDARY INFUSION OF KCL. NURSE NOTED THAT THE SECONDARY WAS DRIPPING VERY QUICKLY AND THE VOLUME WAS INCREASING IN THE NORMAL SALINE PRIMARY BAG. TUBING WAS CHANGED. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADD'L EVENT OR PT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 2420-0500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | HOSPIRA, SECONDARY SET, MODEL NUMBER UNK |