BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2904228 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00637
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    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). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. 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 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) 2012 A NURSE REPORTED THAT ON THE SAME DAY, A HOMECHOICE PEDIATRIC LOW FILL VOLUME CASSETTE WAS USED FOR A PATIENT'S THERAPY. WHEN THE CASSETTE WAS REMOVED FROM THE HOMECHOICE, THE LINE DISCONNECTED FROM THE CASSETTE. THE SET DID NOT LEAK. THE PATIENT WAS BEING TREATED PROPHYLACTICALLY FOR PERITONITIS WITH ANTIBIOTICS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE NURSE REPORTED ON (B)(6) 2013 THAT THIS INCIDENT HAD OCCURRED PREVIOUSLY AS WELL, ON AN UNSPECIFIED DATE. THE PREVIOUS OCCURRENCE HAPPENED WHEN PUTTING THE CASSETTE INTO THE HOMECHOICE. THERE WAS NO PATIENT INVOLVEMENT DURING THIS OCCURRENCE AS THE LINE WAS FOUND TO BE DETACHED FROM THE CASSETTE UPON OPENING THE PACKET PRIOR TO USE. BOTH SAMPLES WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11652 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