BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2930242 · Received January 25, 2013

    Report

    Report Number
    1416980-2013-02011
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF DAMAGED WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION FOUND THAT THE PATIENT LINE WAS DETACHED NEAR THE TACK WELDING OF THE LINE. THE SAMPLE EVALUATION CONFIRMED THE REPORTED PROBLEM. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A NURSE REPORTED THAT ON AN UNSPECIFIED DATE A CASSETTE HAD FALLEN APART. THE LINE HAD DISCONNECTED FROM THE CASSETTE "BOX". THIS HAD OCCURRED PRIOR TO USE, AND WAS DISCOVERED UPON OPENING THE OVERPOUCH. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35831 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE S12G02080

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE