BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1880121 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04777
    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). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DRAIN 4/4 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE PATIENT DISCONNECTED DURING THE DWELL CYCLE AND RECONNECTED BEFORE THE HC ALARMED SYSTEM ERROR 2240. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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 THAT APPEARED WHILE USING THE HOMECHOICE (HC) DURING DRAIN 4 OF 4. THE PATIENT DISCONNECTED DURING THE DWELL CYCLE AND RECONNECTED BEFORE THE HC ALARMED SYSTEM ERROR 2240. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE. GTS HELPED THE PATIENT CLEAR THE ERROR BY CYCLING POWER TWICE TO THE "PRESS GO TO START" PROMPT. THE PATIENT AGREED TO CONTACT THEIR DIALYSIS NURSE AND ELECTED TO COMPLETE THERAPY WITH MANUAL SUPPLIES. 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 69 YR