BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1911110 · Received November 30, 2010

    Report

    Report Number
    1423500-2010-06375
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; HOWEVER, BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER A SUPPLY BAG FELL AND DISCONNECTED. THE LOT INFORMATION WAS 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 BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 2 OF 3. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE PATIENT THAT THE HC HAS DETECTED A LARGE AMOUNT OF AIR IN THE CASSETTE. THE TSR HAD THE PATIENT CLOSE TRANSFER SET AND RECYCLE POWER. THE TSR THEN ADVISED THE PATIENT THAT THE THERAPY HAS ENDED AND THEY WILL NEED TO START OVER WITH NEW SUPPLIES OR DO FINISH WITH A MANUAL EXCHANGE. THE PATIENT ELECTED TO COMPLETE THERAPY MANUALLY. THE TSR ADVISED THE PATIENT THAT THEY WILL NEED TO CONTACT THEIR DIALYSIS NURSE REGARDING THE ERROR AND THE BAG DISCONNECTING. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO STATED THAT SHE WAS NOT ABLE TO RETRIEVE THE LOT NUMBER FOR THE CASSETTE. THE PATIENT STATED THAT THE TSR ASKED HER IF A BAD DISCONNECTED AND THAT IS WHEN SHE FOUND IT ON THE FLOOR. THE PATIENT DID NOT KNOW WHAT CAUSED THE DISCONNECTION AS SHE WAS SLEEPING. THE PATIENT STATED THAT THE SUPPLIES WERE DISCARDED. 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