BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2163247 · Received July 15, 2011

    Report

    Report Number
    1423500-2011-09059
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 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). THIS COMPLAINT FOR SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS IDENTIFIED TO BE USE ERROR FROM THE PATIENT LEAVING THE CLAMP OPEN ON AN UNUSED LINE. 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. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. THEREFORE THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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 GLOBAL TECHNICAL SERVICES REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 ALARM DURING DWELL 2 OF 4 ON THE HOMECHOICE MACHINE. THE CAREGIVER (CG) STATED THAT THE UNUSED SUPPLY LINE HAD THE CLAMP OPEN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO CYCLE POWER TO CLEAR THE ALARM. THE TSR ASSISTED THE CG TO END THERAPY. 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 76 YR HOMECHOICE