BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2181821 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09865
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE REPORTED ISSUE VOLUME WAS NOT LOUD ENOUGH WAS DUPLICATED DURING THE PAL EVALUATION. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE VOLUME WAS NOT LOUD ENOUGH WAS DETERMINED TO BE CAUSED BY AN INOPERATIVE SPEAKER. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM WITH THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A VOLUME ISSUE ON A HOMECHOICE (HC) MACHINE DURING USE. THE VOLUME WOULD NOT GO ANY LOUDER AND THE HOME PATIENT (HP) COULD BARELY HEAR THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE MACHINE. THE TSR DID NOT DISCUSS THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) AS THE HC WAS OPERATIONAL. THERE WAS A PATIENT INVOLVED, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1