BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2073285 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05219
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    November 21, 2010
    Report Date
    November 21, 2010
    Manufacturer
    BAXTER HEALTHCARE ? SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS INVESTIGATED IN (B)(4) WORKSHOP ON (B)(4) 2011. SYSTEM ERROR 2330 CORRESPONDS TO HEATER PLATE RUNAWAY. THE ISSUE WAS CONFIRMED AND RESPONSIBLE PARTS WERE DETERMINED AS FAULTY: THERMO BOARD AND ACCOMP BOARD. THERMO BOARD PCB AND ACCOMP BOARD WERE CHANGED TO NEW ONES. HEATER PLATE AND THERMOCOUPLE BREAKER WERE TESTED AND WERE WORKING CORRECTLY. THIS SAFETY OVERHEAT SYSTEM WAS WORKING LIKE INTENDED AND IT IS DESIGNED TO AVOID OVERHEATED FLUID TO BE INFUSED INTO THE PATIENT. ALSO, SYSTEM ERROR 2330 ALARMS OCCUR TO AVOID INFUSING UNDER OR OVERHEATED FLUID INTO A PATIENT. DEVICE WAS FULLY TESTED AND CALIBRATED DURING EVALUATION. NO FURTHER ISSUES WITH SYSTEM ERROR 2330 ALARM WERE OBSERVED. PER THE SERVICE HISTORY, THE LAST MAINTENANCE WAS DONE (B)(4) 2010. LAST CALIBRATION WAS DONE (B)(4) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL COMPLAINT OF AN UNKNOWN AMOUNT OF SYSTEM ERROR 2330 ALARMS. THE MOST RECENT OCCURRENCE HAPPENED IN DRAIN 3 OF 5. A SWAP OF THE HOMECHOICE UNIT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE ? SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1