BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1905503 · Received November 23, 2010

    Report

    Report Number
    1423500-2010-06110
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED WHEN THE DEVICE WAS RETURNED TO THE BAXTER TAMPA BAY FACILITY FOR EVALUATION. AN EXTERNAL INSPECTION FOUND THE COVER ASSEMBLY AND DOOR COVER CRACKED. THE COVER WAS OPENED AND AN INTERNAL INSPECTION PERFORMED. NO PROBLEMS WERE REVEALED DURING THIS INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. THE REPORTED ISSUE OF NOT ALARMING WAS NEITHER CONFIRMED IN THE LOGS NOR DUPLICATED DURING THE EVALUATION. THE PREVIOUS RETURN WAS NOT ANY ISSUES RELATED TO THE REPORTED ISSUE. DEVICE SENT TO SERVICE. 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 REQUEST ASSISTANCE ON THE HOME CHOICE (HC) MACHINE. PER THE INITIAL REPORT, THE HOME PATIENT (HP) INSISTED ON HAVING THE HC SWAPPED BECAUSE IT DOES NOT TELL HIM THAT HE HAD THE LOW DRAIN VOLUME ALARM. THE HP STATED THE HC WAS NOT ALARMING AND WAS LEAVING TOO MUCH SOLUTION IN HIM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP HOW HE CLEARS THE ALARM AND THE HP STATED THE HC MOVES ON BY ITSELF. THE HP STATED THAT WHEN THE HC DOES NOT DRAIN HIM COMPLETELY AND GOES TO FILL HE HAS DISCOMFORT IN HIS STOMACH. THE TSR EXPLAINED THE HC WOULD BE SWAPPED AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS UNTIL THE MACHINE IS REPLACED. THE HP STATED HE CAN PROGRAM THE NEW HC. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010 PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF DISCOMFORT AND ISSUES WITH THE HC. THE PDN STATED SHE WAS AWARE THE HP WAS GETTING A NEW HC BUT DID NOT KNOW IF HE RECEIVED IT YET. THE PDN STATED THE HP HAS NOT REPORTED ANY SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1