BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE ADMINISTRATION SET

    MDR report key: 3940423 · Received April 17, 2014

    Report

    Report Number
    9616066-2014-00332
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 21, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORT THAT PCA TUBING HAD A CRACK AND WAS LEAKING. THE CUSTOMER STATED THE SET HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PCA TUBING WAS LEAKING, THERE WAS A CRACK IN THE TUBING. CHANGED OUT TUBING AND RESTARTED PCA WITH SAME SETTINGS. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236064 ALARIS PCA MODULE ADMINISTRATION SET FPA CAREFUSION CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT AND PCA MODULE, SN UNK