BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2862589 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06728
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 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 WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION CAN BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF IIPV WAS CONFIRMED BASED ON REPORTED DRAIN VOLUMES. 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 HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT. THE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN ALARM, DURING DRAIN 3, ON A HOMECHOICE MACHINE (HC). THE HOME PATIENT (HP) STATED THAT HE GETS THIS ALARM WHEN HE IS USING TWO RED BAGS. THE HP STATED THAT HE NORMALLY USES 2 GREEN BAGS. HOWEVER, WHEN HE STARTS TO FEEL OVERLOADED AND HIS EDEMA GETS BAD (SWELLING OF LEGS AND ANKLES) HE SWITCHES TO THE RED BAGS, TO PULL THE FLUID OFF. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) OFFERED THE HP A SWAP OF THE DEVICE. THE HP STATED THEIR CYCLE 3 ULTRAFILTRATION WAS 2964ML AND THEIR CURRENT FILL VOLUME OF 2300ML. THE NURSE WAS CONTACTED ON (B)(6) 2012. THE NURSE STATED THAT THE HP DID NOT DEVELOP ANY ADVERSE REACTIONS NOR REQUIRE ANY MEDICAL INTERVENTION. THE NURSE STATED THAT THE HP DID NOT REPORT ANY FURTHER ISSUES AND THEY WERE CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. A HIGH DRAIN 103/CALL PD NURSE ALARM INDICATES THAT THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, WHICH MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE HC UNIT WAS OPERATIONAL AND WAS NOT SWAPPED. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE