FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 3897020
·
Received May 16, 2014
Report
- Report Number
- 9616066-2014-00476
- Event Type
- Malfunction
- Date Received
- May 16, 2014
- Date of Event
- April 30, 2014
- Report Date
- April 30, 2014
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PT INFO REQUESTED AND ALL AVAILABLE INFO WAS INCLUDED. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVAL IS COMPLETED.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT "NURSE VISUALIZED THE SECONDARY VANCOMYCIN INFUSION FLOWING INTO PRIMARY BAG." THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT/EVENT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294591 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORP | 2426-0500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | SECONDARY ADMINISTRATION SET, MODEL 72215N,| LOT # UNK |