BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1972883 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01204
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 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 THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR (SE) 2240 THAT OCCURRED DURING THE INITIAL DRAIN. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO CYCLE THE POWER TO CLEAR THE ALARM. THE TSR EXPLAINED THE ALARM TO THE HP AND INFORMED HER THAT SHE WOULD NEED TO START OVER WITH NEW SUPPLIES. THE HP STATED THAT SHE WOULD JUST WAIT TO DO THERAPY. THE TSR STRONGLY ADVISED THE HP TO CALL HER PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) IF SHE WASN'T GOING TO DO THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP, THE HP STATED, SHE THINKS SHE MAY HAVE DISCONNECTED HERSELF TO USE THE RESTROOM AND WHEN SHE CAME BACK TO RECONNECT, SHE RECEIVED THE ALARM. PER THE HP, SHE IS NOT EXACTLY SURE WHAT COULD HAVE HAPPENED AND DOES NOT HAVE ANY FURTHER INFORMATION AS SHE DOES NOT REMEMBER THAT PARTICULAR ALARM. NO PATIENT 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 72 YR HOMECHOICE CYCLER