BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1933712 · Received December 21, 2010

    Report

    Report Number
    1423500-2010-07094
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 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 A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. THE CAUSE WAS IDENTIFIED AS THE SUPPLY BAG FELL AND BECAME DISCONNECTED. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    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 3. THE PATIENT STATED A SUPPLY BAG FELL AND DISCONNECTED. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TO THE PRESS GO TO START PROMPT. THE PATIENT WAS UNSURE IF SHE WAS GOING TO START OVER WITH NEW SUPPLIES. THE PATIENT ELECTED TO CONTACT THEIR NURSE FOR FURTHER THERAPY ADVICE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED THEY WENT TO THE DIALYSIS CLINIC RIGHT AWAY TO PERFORM A MANUAL EXCHANGE. THE LOT NUMBER WAS NOT AVAILABLE. THE PATIENT DID NOT PROVIDE ANY FURTHER INFORMATION. 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)