FDA Adverse Event
Malfunction
Summary report: N
ALARIS® PUMP MODULE ADMINISTRATION SET
MDR report key: 4791596
·
Received May 22, 2015
Report
- Report Number
- 9616066-2015-00668
- Event Type
- Malfunction
- Date Received
- May 22, 2015
- Date of Event
- January 16, 2015
- Report Date
- April 10, 2015
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED. NO INVESTIGATION WAS PERFORMED. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE PRIMARY SET IV LINE SPONTANEOUSLY DISCONNECTED AT THE DISTAL END LUER CONNECTION TO A NON-CAREFUSION FILTER EXTENSION TUBING DURING A MANNITOL INFUSION. THE NURSE REPLACED THE MANNITOL BAG, IV SET, AND FILTER EXTENSION TUBING AND RECOMMENCED THE INFUSION TO COMPLETE THE ORDERED DOSE. THERE WAS NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335747 | ALARIS® PUMP MODULE ADMINISTRATION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | 11607787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |