BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1980797 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01585
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    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 (AIR IN SET) DURING INITIAL DRAIN, IN THE PREVIOUS NIGHT'S THERAPY WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH AN ALARM WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN, IN THE PREVIOUS NIGHT'S THERAPY. (B)(4) REVIEWED THE ALARM LOG WITH THE PATIENT AND FOUND THAT THE HC ALARMED WITH A SYSTEM ERROR 2240. THE PATIENT EXPLAINED HE THOUGHT HE WAS CONNECTED, BUT COULD NOT VERIFY. PRODUCT SURVEILLANCE SPOKE WITH THE PATIENT'S DIALYSIS NURSE WHO EXPLAINED THE PATIENT HAS A HISTORY OF NONCOMPLIANCE, SKIPPING THERAPY IF A PROBLEM ARISES INSTEAD OF CALLING BAXTER FOR ASSISTANCE. SHE ADDED THAT THE PATIENT WAS IN THE CLINIC TODAY FOR AN APPOINTMENT WITH THEIR NURSE AND NEPHROLOGIST. THE PATIENT REPORTED SKIPPING THERAPY AGAIN "FOR A FEW DAYS". NO ADVERSE SYMPTOMS WERE REPORTED BY THE PATIENT FOR THIS INCIDENT. DURING THE CLINIC VISIT, THE DOCTOR TALKED TO THE PATIENT ABOUT NONCOMPLIANCE, THE IMPORTANCE OF DAILY THERAPY AND REPORTING ANY PROBLEMS TO HIS NURSE. THE PATIENT CHECKED OUT OK AND RETURNED HOME.

    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 62 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)