BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 4203544 · Received September 17, 2014

    Report

    Report Number
    9616066-2014-00928
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    August 21, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TUBING SEPARATED FROM THE BAG SPIKE. THERE WAS NO PT HARM OR MED INTERVENTION. NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575458 ALARIS PUMP MODULE ADMIN SET IV INFUSION SET FPA CAREFUSION CORP 10013037 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK