BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2092031 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06126
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - TAMPA
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, 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) REPAIR CENTRE. THE ISSUE WAS NOT CONFIRMED. ELECTRICAL SAFETY TEST PASSED. POWER CORD WAS IN GOOD CONDITION, WITHOUT ANY DAMAGE. THE DEVICE WAS TESTED USING MULTI METER, ELECTRICITY ON DEVICE HOUSING WAS NOT FOUND. AFTER OPENING THE DEVICE ALL GROUNDING POINTS WERE MEASURED. ALL READINGS WERE BELOW 0.2 OHMS, WHICH IS IN RANGE. EMPIRICAL ECLECTIC SHOCK TEST WAS DONE, WITHOUT ANY SHOCK EXPERIENCES OR OBSERVATIONS. DEVICE WAS FULLY TESTED AND CALIBRATED DURING EVALUATION. THE ROOT CAUSE OF COMPLAINT WAS NOT DETERMINED. DEVICE WORKS LIKE INTENDED.

    Description of Event or Problem · 1

    THIS IS A REPORT RECEIVED BY BAXTER (B)(4). THE PATIENT REPORTED THE ELECTRIC SHOCK ON HER DEVICE WHEN TOUCHED DURING PATIENT USE. THE PATIENT WANTED TO SWAP THE HOMECHOICE DEVICE. NO CLINICAL IMPACT ON THE PATIENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1