BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE, DOMESTIC 120V

    MDR report key: 1973069 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01212
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED AND EVALUATED. THE REPORTED PROBLEM OF HC SMELLING LIKE SOMETHING WAS BURNING, WAS NEITHER CONFIRMED IN THE DEVICE LOGS OR DUPLICATED DURING THE EVALUATION. A DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE BAXTER TECHNICIAN PERFORMED AN EXTERNAL /INTERNAL INSPECTION AND DID NOT FIND ANY EVIDENCE OF COMPONENTS OVERHEATED OR ANY SIGNS OF HEAT DAMAGE WITHIN THE HC DEVICE. THERE WERE NO POWER FAILURES OR SYSTEM ERRORS RELATED TO POWER ISSUES RECORDED IN THE LOGS. DEVICE POWER WAS CYCLED ON/OFF SEVERAL TIMES. NO PROBLEMS WERE ENCOUNTERED; ALSO THERE WAS NO SMELL OF BURNING, WHILE THE DEVICE WAS RUNNING. THE CAUSE FOR THE REPORTED ISSUE IS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A BURNING SMELL THE LAST COUPLE OF DAYS WHEN THE HOMECHOICE (HC) DEVICE IS RUNNING. THE HOME PATIENT (HP) STATED WAS IN DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED HP TO DISCONNECT FROM THE HC AND USE MANUAL SUPPLIES FOR TONIGHT AND CONTACT THE NURSE. THE TSR WILL SWAP HC DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE HOME PATIENT (HP) REGARDING THE BURNING SMELL, IT WAS REVEALED THAT THE HOMECHOICE (HC) MACHINE WAS REPLACED, AND THAT SHE HAD NOT HAD ANY PROBLEMS SINCE. THE HP CONFIRMED THAT SHE DID NOT HAVE ANY ISSUES WITH THERAPY OR ANY MEDICAL ISSUES WHILE ON THE HC MACHINE THAT HAD THE BURNING SMELL. PER HP, SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR