BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1901473 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05892
    Event Type
    Malfunction
    Date Received
    November 17, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DIFFICULTY OF A 6000 ML INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS NEITHER CONFIRMED IN THE DEVICE LOGS NOR DUPLICATED DURING EVALUATION. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. THE ASSIGNABLE CAUSE OF A 6000 ML IIPV DRAIN VOLUME WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE HOME CHOICE (HC) WAS NOT ALARMING WITH A LOW DRAIN VOLUME ALARM DURING THE INITIAL DRAIN AND THE HOME PATIENT (HP) HAD AN OVERFILL EVENT. THE REGISTERED NURSE (RN) WANTED TO SWAP THE HC. THE RN STATED SHE PERFORMED A MANUAL DRAIN ON THE HOME PATIENT (HP) AND DRAINED APPROXIMATELY 6L. THE RN STATED THAT THE HC DID NOT GIVE ANY ALARMS FOR LOW DRAIN VOLUME ALARM DURING THE INITIAL DRAIN WHEN THE HP DRAINED 64ML FROM THE LAST FILL VOLUME OF 2000ML AND THE HC MOVED TO FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE RN CHECK THE INITIAL DRAIN ALARM (IDA) SETTING AND IT WAS SET TO 0ML. THE TSR EXPLAINED THIS COULD HAVE POSSIBLY CAUSED THE IIPV SITUATION. THE TSR ARRANGED FOR SWAP. THE RN WOULD PROGRAM THE NEW HC. THE HP HAS MANUAL SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010, (B)(4) CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF OVERFILL. THE PDN STATED THE HP WAS HAVING SOME FIBRIN PROBLEMS AND HAS BEEN INSTRUCTED TO USE HEPARIN. THE PDN STATED THE HP HAS BEEN RETRAINED ON THE HC AND HAS BEEN INFORMED NOT TO BYPASS ANY ALARMS. 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 68 YR