BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2171707 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09291
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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 NOT RETUNED FOR EVALUATION THEREFORE THE REPORTED ISSUE OF BURNING ODOR COULD NOT BE CONFIRMED. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE WAS UNDETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO A BURNING SMELL. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE SMELLED A BURNING SMELL FROM THE HOMECHOICE (HC) MACHINE. THE HC DID NOT ALARM WITH A SYSTEM ERROR. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE ASKED THE HOME PATIENT (HP) IF HE WOULD LIKE HIS HC SWAPPED. THE HP STATES HE WOULD NOT AND THAT HE WILL START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORT OF A BURNING SMELL. THE HP STATED THAT HE SMELLED SOMETHING BURNING AND THOUGHT IT WAS COMING FROM THE HC. THE HP AND HIS WIFE WENT AROUND THE HOUSE TO SEE IF THEY COULD SMELL THE SMOKE SMELL SOMEWHERE ELSE IN THE HOME. THE HP ALSO WENT OUTSIDE TO SEE IF THE SMELL WAS COMING FROM OUTSIDE. THE HP, NOR IS WIFE, SMELLED SMOKE ANYWHERE ELSE. THE HP SAID THAT WHEN THEY RETURNED TO THE ROOM THEY COULD NOT SMELL THE SMOKE SMELL ANYMORE. THE HP SAID THAT HIS WIFE DOES ROUTINELY WIPE THE HOMECHOICE DOWN WITH THE SAME CLEANING FLUID THAT THE HP USES TO CLEAN IS TRANSFER SET WITH. THE BURNING SMELL HAS NOT RETURNED AND THE HP HAS BEEN USING THE CYCLER WITH NO FURTHER REPORTED ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    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 60 YR