BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD DISCONNECT Y SET

    MDR report key: 4926424 · Received July 20, 2015

    Report

    Report Number
    1416980-2015-29532
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Report Date
    June 25, 2015
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA WAS REFERENCED FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION WAS PERFORMED WITH NAKED EYE AND MAGNIFICATION AND FOUND EXCESS SOLVENT AND TUBING STUCK TO THE BAG. FUNCTIONAL TESTING PERFORMED INCLUDED LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS EXCESS SOLVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A CAPD DISCONNECT Y SET WAS STUCK TO THE BAG, AND UPON SEPARATION RESULTED IN A HOLE IN THE BAG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469076 CAPD DISCONNECT Y SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H14L11015

    Patients

    Seq Age Sex Outcome Treatment
    1