BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1062648 · Received June 11, 2008

    Report

    Report Number
    1423500-2008-00478
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADD'L PMA/510(K): K923065. H3: CUSTOMER SAMPLE RECEIVED; HOWEVER, EVAL NOT YET COMPLETED.

    Description of Event or Problem · 1

    THE WIFE OF THE HOME PATIENT (HP) CONTACTED A TECHNICAL SERVICE REP (TSR) AND REPORTED THE HP WAS BLOATED WITH A DISTENDED ABDOMEN, AS IF HE WERE OVERFILLED, AT THE END OF THE THERAPY USING THE HOMECHOICE AUTOMATED PERITONEAL DIALYSIS (APD) SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE HP'S TOTAL ULTRAFILTRATION (UF) WAS - 749 MLS. ACCORDING TO THE HP'S WIFE, THE HP'S TYPICAL TOTAL UF IS AROUND +1000MLS. THE TSR VERBALLY ASSISTED THE HP TO PERFORM A MANUAL DRAIN AND THE HP REMOVED 2100MLS OF FLUID, WHICH WAS 2000MLS GREATER THAN THE PT'S LAST FILL VOLUME RECEIVED OF 100MLS. THE TSR SUBSEQUENTLY SWAPPED THE CUSTOMER'S DEVICE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1