BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2200510 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10536
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 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) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. 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). BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING ASSISTANCE FOR TROUBLESHOOTING A SYSTEM ERROR (SE) 2240 AND 2367 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN; THE HOME PATIENT (HP) STATED THAT THIS ALARM HAD OCCURRED A COUPLE OF TIMES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) TOLD THE HP TO REDO THE SETUP AND START THE INITIAL DRAIN OVER. THE TSR TOLD THE HP TO CONTACT THEIR NURSE IN THE MORNING REGARDING THE REPORTED PROBLEM. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED THEY DID START OVER WITH NEW SUPPLIES. THEY STATED THEY DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES THAT COULD HAVE LED TO THE ALARM. THE HP STATED THAT THERAPY HAS BEEN GOING FINE SINCE THEN. ALL SUPPLIES WERE DISCARDED AFTER USE, AND THEY DO NOT RECALL THE LOT NUMBER. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SUBMITTED FOR MEDWATCH PEER REVIEW FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE