BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1911954 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06415
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 6, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON 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. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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 DWELL 5 OF 6. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TO CLEAR THE ERROR. GTS THEN ADVISED THE PATIENT TO DISCARD THE SUPPLIES AND EITHER START OVER WITH NEW SUPPLIES OR FINISH WITH MANUAL SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT. THE PATIENT STATED THAT NOTHING WAS NOTICED WITH THE SUPPLIES, BUT THAT THEY HAD THE LOT NUMBER AND A COMPANION SAMPLE. PRODUCT SURVEILLANCE REQUESTED THE SAMPLE FOR EVALUATION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR