BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2175417 · Received July 25, 2011

    Report

    Report Number
    1423500-2011-09450
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    BAXTER DISTRIBUTOR REPORTED SYSTEM ERROR 2240 AGAINST SEVERAL CASSETTES USED ON THE HOMECHOICE MACHINE (HC), WHICH OCCURRED DURING THE DWELL CYCLES. THERE WAS NO PATIENT INJURY, ONLY DISCOMFORT. THE REPLENISH OF THE HEATER BAG WITH FLUID OF THE SUPPLY BAGS STARTS. AT A CERTAIN MOMENT WHEN THE SUPPLY BAGS HAVE EMPTIED AND THE HEATER BAG IS FULL, THE DEVICE CONTINUES TO SUCK AIR INSTEAD OF FLUID. THERE IS AIR VISIBLE IN THE DRAIN BAG, AS WELL AS THE SUPPLY LINES OF THE DISPOSABLE CASSETTE AND DRAIN LINE. IT IS BEING CLAIMED THAT THE BLACK ELASTIC SEAL RING OF THE EMO-LUER VALVE DOES NOT WORK PROPERLY. THIS IS REPORT 5 OF 6.

    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 HOMECHOICE