BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2903359 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00577
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED OVER THE PHONE. REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN 104 ALARM AT THE END OF THERAPY ON THE HOMECHOICE MACHINE(HC). THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE HOME PATIENT(HP) TO CLEAR THE ALARM AND REVIEW THE ULTRAFILTRATION(UF) RESULTS FOR THERAPY. THE HP HAD A CYCLE 1 UF OF 255ML, CYCLE 2 UF OF -130ML, CYCLE 3 UF OF -250ML, AND CYCLE 4 UF OF 2026ML. THE HP STATED SHE NEVER FELT ANY DIFFERENT AND SHE IS FILLING FINE NOW. THE TSR STATED THEY WOULD NOTIFY THE NURSE OF THE ALARM MEANING. THE NURSE WAS CONTACTED ON (B)(4) 2012. THE NURSE STATED THAT THE HP DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE NURSE STATED THE HP DID NOT REPORT ANY FURTHER ISSUES AND THEY WERE CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THE HC UNIT WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12949 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE