BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1880080 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04776
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 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). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DRAIN 4 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 THAT APPEARED WHILE USING THE HOMECHOICE (HC) DURING DRAIN 4. GTS HAD THE PATIENT CLOSE ALL THE CLAMPS AND TRANSFER SET BEFORE CYCLING POWER TWICE TO CLEAR THE ALARM. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE. THE PATIENT STATED THE ERROR OCCURRED IN DRAIN 4, THERE WERE NO LEAKS, AND THEY DID NOT DISCONNECT PRIOR TO THE ERROR. GTS NOTED AT THE TIME OF THE CALL THAT THE PATIENT WAS NOT CONNECTED TO THE PATIENT LINE. ALL OF THE LINES WERE IN USE, AND THERE WERE NO SPARE LINE CLAMPS OPEN. GTS ADVISED THE PATIENT TO DISCARD THE SUPPLIES AND REPORT THE ERROR TO THEIR DIALYSIS NURSE THE NEXT MORNING. THE PATIENT ELECTED TO COMPLETE THERAPY MANUALLY. GTS REVIEWED PROPER PROCEDURE 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 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR