BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1045711 · Received May 14, 2008

    Report

    Report Number
    1423500-2008-00355
    Event Type
    Injury
    Date Received
    May 14, 2008
    Date of Event
    May 13, 2007
    Report Date
    May 14, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKK
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR SIMULATED PT THERAPIES WERE ATTEMPTED USING THE PT'S THERAPY SETTINGS. THREE WERE ABORTED DUE TO SYS ERROR (SE) 2201 AND ONE WAS ABORTED DUE TO A SE 2088. THE SOFTWARE WAS THEN USED TO MONITOR THE DEVICES PNEUMATIC SYS. NO PROBLEMS WERE REVEALED AND ALL PRESSURES WERE CORRECT AND STABLE. THE DEVICE PASSED THE SEAL & PURGE TEST AND THE WET DISPOSABLE TEST. THE COVER WAS OPENED AND AN OVERALL GENERAL INTERNAL INSPECTION PERFORMED ON THE DEVICE. ALL CONNECTIONS APPEARED CORRECT AND SECURE. THE INSPECTION DID REVEAL FLUID WITHIN THE VOLUMETRIC STANDARD RIGHT (VSR) CUP AND THE VSR TUBING. BECAUSE FLUID WAS PRESENT IN THE PNEUMATIC SYS THE DEVICE REPEATEDLY ALARMED AND ACCURACY TESTING COULD NOT BE PERFORMED. THE FLUID IN THE PNEUMATIC SYS CAUSED THE DEVICE TO FAIL IN A SAFE MODE BY ALARMING 2201 AND 2088 AS THE PAL ENCOUNTERED AS WELL AS THE 160 AND 177 RECORDED IN THE ALARM LOG. ANY FLUID WITHIN THE PNEUMATIC SYS CAN CAUSE NUMEROUS ERRORS. THE REPORTED DIFFICULTY OF SE 2001 (LEFT VOLUME INITIAL CALCULATION(, RLS 160 (LEFT DISPOSABLE VOLUMETRIC FINAL MAXIMUM FAILED) AND RLS 177 (POST AND RD DO NOT COMPARE) WERE ALL CONFIRMED IN THE ALARM LOG. THE REPORTED DIFFICULTY OF SEVERE OVERFILL WAS NOT CONFIRMED IN THE LOGS OR DUPLICATED DURING TESTING. THE EVENT LOG WAS DOWN LOADED AND THERAPY AND ALARM LOGS WERE OBTAINED. SIMULATED PT THERAPIES WERE ATTEMPTED. THE DEVICE SVC RECORD WAS REVIEWED. INTERNAL AND EXTERNAL VISUAL INSPECTIONS WERE PERFORMED. FLUID WAS FOUND WITHIN THE PNEUMATIC SYS. THE REPORTED DIFFICULTY OF SEVERE OVERFILL WAS NOT CONFIRMED IN THE LOGS OR DUPLICATED DURING TESTING. AN INTERNAL INSPECTION REVEALED FLUID WITHIN THE VOLUMETRIC STANDARD RIGHT ERRORS, INCLUDING THE ONES ENCOUNTERED IN THE PROD ANALYSIS LAB (PAL) AS WELL AS THE RECORDED SE'S CONTAINED IN THE LOGS. DUE TO THE FLUID WITHIN THE PNEUMATIC SYS, FURTHER TESTING WAS NOT ABLE TO BE PERFORMED. THE DEVICE WILL BE SCRAPPED.

    Description of Event or Problem · 1

    THE REGISTERED NURSE (RN) CONTACTED BAXTER'S TECHNICAL SVC CTR REGARDING THE HOME PT (HP) NOT BEING ABLE TO DO DIALYSIS FOR THE LAST TWO DAYS DUE TO ALARMS. THE TSR REVIEWED THE ALARM LOG SEVERAL SYS ERROR 2001 ALARMS, A RELOAD SET 160 ALARM AND A RELOAD SET 177 ALARM. THE HP KEPT ENDING THE THERAPY AND ATTEMPTED SEVERAL TIMES TO DO THERAPY BY SETTING UP WITH NEW SUPPLIES. THE RN SAID THAT THE HP WAS SEVERELY OVERFILLED BECAUSE SHE HAD NOT DONE THE THERAPY CORRECTLY FOR THE PAST TWO DAYS. FOR THE PAST TWO DAYS, THE HP HAS BEEN GETTING SEVERAL ALARMS. THE HP HAS MADE SEVERAL ATTEMPTS TO DO THERAPY BY SETTING UP WITH NEW SUPPLIES. THE RN WILL PROGRAM. BAXTER'S TECHNICAL SVC CTR ARRANGED A SWAP OF THE INSTRUMENT DUE TO THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening