BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3964986 · Received July 29, 2014

    Report

    Report Number
    1416980-2014-24582
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. VISUAL INSPECTION WAS PERFORMED WITH BOTH THE NAKED EYE AND A MICROSCOPE, AND DAMAGE TO THE LIGHT BLUE MAIN BODY WAS FOUND IN THE FORM OF CRACKS. LEAK TESTING WAS PERFORMED WITH UNDERWATER PRESSURE TESTING, WITH NO LEAKS FOUND. CLEAR PASSAGE AND CLAMP FUNCTION TESTING WAS PERFORMED WITH NO ISSUES NOTED. UPON COMPLETION OF THE INVESTIGATION, THE REPORTED PROBLEM OF DAMAGE TO THE MAIN BODY WAS VERIFIED; HOWEVER, THE CAUSE WAS UNDETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE CRACKS ON THE LIGHT BLUE PORTION OF A MINICAP TRANSFER SET. THIS WAS IDENTIFIED AFTER PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441065 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1