BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

    MDR report key: 1760739 · Received July 19, 2010

    Report

    Report Number
    1423500-2010-01530
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2010 THAT HOMECHOICE PRO SEEMED TO HAVE DELIVERED AN UNSCHEDULED FULL FILL DURING THE TIDAL PROGRAM. THE FULL FILL WAS DELIVERED IN CYCLE 4 AND 7. THE LARGEST PRESCRIBED FILL VOLUME WAS 1500ML. THE CYCLE BY CYCLE THERAPY LOG INDICATED THAT THE OVERFILL OCCURRED IN DURING CYCLE 9 DRAIN. THE PATIENT DRAINED 3427ML. THIS EVENT MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR