BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1911233 · Received November 30, 2010

    Report

    Report Number
    1423500-2010-06398
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 2, 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). RESOLVED OVER THE PHONE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S DIALYSIS NURSE. SHE STATED THAT THE PATIENT DID NOT NOTIFY THE CLINIC OF THE ERROR. THE NURSE STATED THAT THE PATIENT IS DOING FINE AND THAT SHE WOULD FOLLOW-UP WITH THE PATIENT SOON. THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT HAD NOT CONNECTED WHEN THERAPY INITIATED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS PATIENTS ON THE PROPER SEQUENCE OF STEPS TO PERFORM BEFORE PATIENT CAN PRESS "GO" TO START THE THERAPY. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. THIS INCIDENT WAS RESOLVED OVER THE PHONE USING THE CURRENT LABEL COPY. 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 GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TWICE TO CLEAR IT. GTS THEN EXPLAINED THAT THE PATIENT NEEDED TO START OVER WITH NEW SUPPLIES AND THAT THEY WOULD NEED TO CALL THEIR DIALYSIS NURSE WITHIN 24 HOURS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR