BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3941431 · Received April 16, 2014

    Report

    Report Number
    9616066-2014-00397
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    April 3, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MFR. THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TUBING BALLOONED DURING AN INFUSION. THE PT HAD A CLOTTED PORT-A-CATH MIGHT HAVE CAUSED ENOUGH BACK PRESSURE UPSTREAM TO CAUSE THE BALLOON. THE PORT-A-CATH WAS DETERMINED TO BE INFECTED SO IT WAS REMOVED. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232160 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2433-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PUMP MODULE, SN UNK| PORT-A-CATH, MODEL/LOT UNK| ALARIS PC UNIT, SN UNK