BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE SET

    MDR report key: 5753178 · Received June 27, 2016

    Report

    Report Number
    9616066-2016-00824
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    May 4, 2016
    Report Date
    May 31, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: MEDLINE SYRINGE SWABFLUSH (ZR FLUSH SYRINGE W/INTEGRATED SWABCAP) MODEL E0103-01, LOT # 3127060, EXP 01/01/2018; THERAPY DATE: (B)(6) 2016. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA, WHICH STATES "A NURSE STATED SHE HAD OBSERVED AT LEAST 3 TIMES PCA TUBING LEAKING AT A PORT WITH A FLUSH SYRINGE CONNECTED TO IT. IT IS UNKNOWN IF THE LEAK IS FROM A FAULTY FLUSH SYRINGE OR TUBING PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407026 ALARIS PCA MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10800173

    Patients

    Seq Age Sex Outcome Treatment
    1