BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2071257 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05107
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. DURING THE INVESTIGATION, A BURNT ODOR WAS COMING FROM THE POWER INPUT MODULE CONFIRMING THE REPORTED ISSUE. THE INPUT MODULE WAS REPLACED AND THE DEVICE PASSED ALL TESTING PER LOCAL PROCEDURES AND PROTOCOLS. VISUAL INSPECTION FOUND NO PHYSICAL DAMAGES. BASED ON THE RESULTS OF THE EVALUATION; THE CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE THE POWER INPUT MODULE. THE POWER INPUT MODULE WAS REPLACED. THE DEVICE WAS SERVICED AND PASSED ALL TESTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A POWER FAILURE ALARM THAT APPEARED ON THE HOMECHOICE (HC) MACHINE DURING DWELL 1 OF 5, THE NURSE STATED THERE WAS AN ELECTRICAL SMELL COMING FROM HC MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE NURSE TO DISCONNECT THE HOME PATIENT (HP) AND COMPLETE THERAPY WITH MANUAL SUPPLIES. THE TSR FURTHER ADVISED THE NURSE THAT THE HC MACHINE WOULD NEED TO BE SWAPPED. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS 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