BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2251725 · Received August 31, 2011

    Report

    Report Number
    9616066-2011-00498
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 15, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K94320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINT OF CHECK VALVE FAILURE COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE CUSTOMER STATED THE SET HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CHECK VALVE FAILURE WITH FLUID VISUALIZED GOING FROM SECONDARY BAG INTO PRIMARY BAG EVEN THOUGH THE HEAD HEIGHT DIFFERENTIAL WAS CORRECT. THE PATIENT WAS RECEIVING METHOTREXATE CHEMO. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2126-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO