BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2040152 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04112
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 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) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. LABEL REVIEW WAS NOT PERFORMED NO USER ERROR WAS SUSPECTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT'S CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THERAPY. THE PATIENT STATED THAT HIS CONNECTION DISCONNECTED AT SOME POINT DURING THE NIGHT. THE PATIENT WOKE UP TO THE HC ALARMING AND WAS NOT CONNECTED TO THE HC. GTS HAD THE PATIENT CYCLE POWER TO CLEAR THE ERROR. GTS THEN ADVISED THE PATIENT TO CONTACT THEIR NURSE IN THE MORNING FOR THERAPY RECOMMENDATIONS. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S CAREGIVER WHO EXPLAINED THEY WERE UNSURE HOW THE PATIENT BECAME DISCONNECTED. THE CAREGIVER STATED, THE PATIENT'S NURSE WAS NOTIFIED AND THAT THEY WENT FOR A VISIT. THE PATIENT WAS PRESCRIBED MEDICATION THAT THEY HAVE TO INJECT INTO THE SOLUTION BAGS EVERY EVENING. THE CAREGIVER STATED THEY HAD NOT HAD ANY OTHER SIGNIFICANT PROBLEMS SINCE REPORTING THE SYSTEM ERROR 2240. 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 72 YR HOMECHOICE