BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1933763 · Received December 21, 2010

    Report

    Report Number
    1423500-2010-07095
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 27, 2010
    Report Date
    November 27, 2010
    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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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 A DWELL CYCLE. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. GTS THEN HAD THE PATIENT CYCLE POWER TO CLEAR THE ERROR. THE PATIENT ELECTED TO COMPLETE THERAPY MANUALLY. (B)(4) CONTACTED THE PATIENT'S DIALYSIS NURSE WHO ADVISED SHE WAS NOT AWARE OF THE ERROR AS SHE HAS NOT HEARD OF ANY PROBLEMS FROM THE PATIENT. THE NURSE EXPLAINED THAT SINCE THE PATIENT HADN'T CONTACTED HER, THE PATIENT SHOULD BE RESUMING THERAPY AS USUAL. THE NURSE ELECTED TO FOLLOW-UP WITH THE PATIENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE APD CYCLER 5C4471R (REFURBISHED)