BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE, DOMESTIC 120V

    MDR report key: 1792108 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02344
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    February 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION ANTICIPATED. FOLLOW UP INFORMATION WILL BE SENT WHEN IT IS MADE AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION THIS REPORT WAS DETERMINED TO BE A DUPLICATE REPORT OF AN ADVERSE EVENT REPORTED UNDER REPORT NUMBER 1423500-2010-00255. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE BAXTER FACILITY IN LATIN AMERICA FOR EVALUATION ON AN UNKNOWN DATE. RESULTS OF THE EVALUATION INDICATE: THE SYSTEM ERROR 2044 IS RELATED TO THE PNEUMATIC SYSTEM OF THE MACHINE. DURING THE MACHINE EVALUATION, DAMAGE WAS OBSERVED ON THE COMPRESSOR THAT CAUSED THE SYSTEM ERROR 2044. THE COMPRESSOR OF THE PNEUMATIC SYSTEM WAS REPLACED. THE MACHINE WAS TESTED FOR 10 HOURS AND ALL RESULTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 25 DAYS FOLLOWING DEVICE REPLACEMENT SURGERY. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    THE NURSE CONTACTED BAXTER (B)(4) AND INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THE HOME CHOICE MACHINE INFUSED 3 TIMES THE NORMAL AMOUNT IN A PATIENT'S PERITONEAL CAVITY ON THE (B)(6) 2010 AT 12:03 PM; THE PATIENT WITHHELD 479 ML OF LIQUID. AFTER THE EVENT THE PATIENT WAS IMMEDIATELY ADMITTED IN THE HOSPITAL ON INTENSIVE THERAPY UNIT (UTI). THE PATIENT PRESENTED WITH SWEATING, DECREASE IN OXYGEN SATURATION WHICH WAS 88% AND ABDOMINAL DISTENSION. THE NURSE REVIEWED THE ALARM REGISTER ON THE MACHINE AND SHE DID NOT OBSERVED AN ERROR ON THE DATE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE, DOMESTIC 120V SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SAO PAULO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R