BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2603776 · Received June 7, 2012

    Report

    Report Number
    1423500-2012-12196
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    BAXTER HEALTHCARE SA (SINGAPORE BRANCH)
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK WAS CONFIRMED DURING THE SAMPLE EVALUATION, AND THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A CRACK IN THE CASSETTE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK IN A CASSETTE WAS CONFIRMED DURING THE SAMPLE EVALUATION. ONE USED CASSETTE WAS RECEIVED AND DURING THE VISUAL INSPECTION, THERE WERE TWO CRACKS FOUND ON THE EDGE OF THE CASSETTE. A FUNCTIONAL INSPECTION WITH A THERAPY PERFORMED AND NO ALARMS SOUNDED BUT THERE WAS SOLUTION ON THE BENCH TOP WHICH LEAKED FROM THE CASSETTE. HOWEVER, NO ROOT CAUSE HAS BEEN DETERMINED BECAUSE THE INVESTIGATION IS STILL NOT COMPLETED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A CASSETTE. THE HOME PATIENT (HP) WAS DOING THERAPY AT NIGHT AND WHEN THEY WOKE UP, THE TREATMENT WAS FINISHED, AND THEY SAW LIQUID ON THE FLOOR, SO THE HP CONTACTED THE HOSPITAL. THERE WAS NO SUCTION SOUND INVOLVED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE SA (SINGAPORE BRANCH)

    Patients

    Seq Age Sex Outcome Treatment
    1