BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2173361 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09328
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 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 A SYSTEM ERROR (SE) 2240 WAS CONFIRMED, AND THE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE SUPPLY BAG FELL AND DISCONNECTED. 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. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED BY THE CUSTOMER. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT 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 (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 ALARM DURING DWELL 2 ON THE HOMECHOICE MACHINE(HC). THE HOME PATIENT STATED THAT A BAG FELL OFF AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE HOME PATIENT(HP) TO CYCLE POWER TWICE TO CLEAR THE ALARMS. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES OR FINISH MANUALLY. THE HP STATED THEY WILL FINISH MANUALLY. THE HP WAS CONTACTED ON (B)(6) 2011. THE HP STATED THIS WAS AN ISOLATED INCIDENT. THE HP ALSO STATED HE DID NOT DEVELOP ANY ADVERSE REACTIONS OR NEED ANY MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION 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 70 YR HOMECHOICE