BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2347459 · Received November 23, 2011

    Report

    Report Number
    1423500-2011-15571
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    November 3, 2011
    Report Date
    November 3, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS UNDETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 ALARM DURING THERAPY ON THE HOMECHOICE MACHINE(HC). THE NURSE STATED SHE HAS THE HOME PATIENT(HP)'S HC AND WAS REVIEWING THE ALARM LOG. THE NURSE STATED SHE NOTICED THE SYSTEM ERROR 2240 ALARM AND SYSTEM ERROR 2367 ALARM. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) EXPLAINED BOTH ALARMS AND POSSIBLE CAUSES. THE NURSE WAS CONTACTED ON (B)(6) 2011. THE NURSE STATED THAT SHE DID NOT KNOW IF THE HOME PATIENT(HP) WAS EVER CONNECTED TO THE DEVICE AT THE TIME OF THE ALARM OR ANY OTHER DETAILS REGARDING THE SYSTEM ERROR 2240. THE NURSE STATED THE HOME PATIENT(HP) HAS NOT REPORTED ANY OTHER ISSUES REGARDING THE SYSTEM ERROR 2240 OR SAMPLE AVAILABILITY. THE NURSE STATED THAT THE HP DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE NURSE STATED THE HP IS CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THE HC UNIT WAS OPERATIONAL. 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 47 YR HOMECHOICE