BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2070178 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05072
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 21, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USER ERROR - FAILED TO FOLLOW THERAPY STEPS WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE CAUSE IS THAT THE PATIENT REUSED A DISPOSABLE SET. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. A BATCH REVIEW WAS NOT PERFORMED, BECAUSE A SAMPLE WAS NOT AVAILABLE. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    WHILE FOLLOWING UP WITH A PATIENT, PRODUCT SURVEILLANCE (PS) LEARNED THE PATIENT CHANGED OUT THE HEATER BAG. PS ASKED IF THE PATIENT ALSO CHANGED OUT THE CASSETTE AND THE PATIENT SAID NO. THE PATIENT STATED SHE HAS BEEN DOING THIS A LONG TIME AND KNOWS WHAT SHE IS DOING. PS ASKED THE PATIENT IF THEY NOTIFIED THEIR NURSE, AND THE PATIENT SAID YES. 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 58 YR HOMECHOICE