BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2092038 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06132
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 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). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SE 2240 ALARM WAS CONFIRMED TO BE CAUSED BY A USE ERROR BASED ON CUSTOMER CONTACT. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGHTIER I (B)(4) AND TIER II (B)(4).

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE NURSE PRESS STOP AND REVIEWED THE ALARM LOG. THE TSR ASKED THE NURSE THE TROUBLESHOOTING QUESTIONS AND EXPLAINED THE ALARM TO THE NURSE. THE TSR EXPLAINED IT IS RECOMMENCED TO START OVER WITH ALL NEW SUPPLIES. THE NURSE CLEARED THE ALARMS BY CYCLING THE POWER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP, THE NURSE SAID THAT SHE JUST SAW THE HOME PATIENT (HP) YESTERDAY AND HER THERAPY WAS GOING REALLY WELL. THE NURSE SAID THAT THE ALARM OCCURRED DURING A MID DAY EXCHANGE AND THEY EVENTUALLY WERE ABLE TO DETERMINE THAT THE HP DISCONNECTED FROM WITHOUT STOPPING THERAPY. THE NURSE SAID THEY ADDRESSED THE USER ERROR. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE