BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2000891 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02431
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR (SE) 2240 ALARM. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS NOT DETERMINED. 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

    THE CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 4. THE CAREGIVER (CG) STATED SHE LOOKED AT ALL THE SUPPLIES AND DID NOT SEEM TO FIND ANYTHING WRONG. THE CG STATED THE HOME PATIENT (HP) WAS CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM INDICATES AIR HAS ENTERED THE SET UP AND ASSISTED THE CG TO CYCLE POWER TO CLEAR ALARM. ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HP'S NURSE WHO STATED THIS PATIENT IS DOING WELL WITH THERAPY AND NO ADVERSE EVENT RESULTED FROM THIS REPORT. THE NURSE CONFIRMED THE PATIENT IS UNDER CARE IN (B)(6) UNTIL (B)(6). ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S WIFE WHO STATED THERAPY WAS GOING FINE AND NO OTHER ISSUES HAVE OCCURRED.

    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 85 YR HOMECHOICE PRO (B)(4)