BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1920380 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06778
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 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). DEVICE WAS REQUESTED FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    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; HOWEVER, PER THE COMPLAINT INFORMATION THE MOST LIKELY CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE SUPPLY BAG BECAME DISCONNECTED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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 (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 FILL 1. GTS HAD THE PATIENT CHECK ALL THE LINES AND BAGS FOR PROBLEMS. THE PATIENT EXPLAINED THAT THE SUPPLY BAG HAD DISCONNECTED FROM THE SUPPLY LINE. GTS ADVISED THE PATIENT THAT A LARGE AMOUNT OF AIR ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TWICE TO CLEAR THE ERROR AND START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT. THE PATIENT EXPLAINED THAT THEY HAVE ONE COMPANION SAMPLE AVAILABLE FOR EVALUATION AND HAS NOT HAD ANY FURTHER ISSUES WITH THERAPY. 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 67 YR