BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2010984 · Received March 8, 2011

    Report

    Report Number
    1423500-2011-02856
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DRAIN 4 OF 4 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE PATIENT DISCONNECTED DURING THE DWELL CYCLE AND THE HC ALARMED. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DRAIN 4 OF 4. THE PATIENT DISCONNECTED DURING THE DWELL CYCLE AND THE HC ALARMED. GTS EXPLAINED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. GTS THEN HELPED THE PATIENT CLEAR THE ERROR BY CYCLING POWER TWICE TO THE "PRESS GO TO START" PROMPT. THE PATIENT ELECTED TO CONTACT THEIR DIALYSIS NURSE AND COMPLETE THERAPY WITH MANUAL SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S DIALYSIS NURSE WHO EXPLAINED THE PATIENT DID NOTIFY THE CLINIC OF THE ERROR AND HAD BEEN DOING WELL SINCE. NO INJURY OR MEDICAL INTERVENTION WAS 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 - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR HOMECHOICE PRO