BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1844340 · Received September 24, 2010

    Report

    Report Number
    1423500-2010-03708
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. THE ASSIGNABLE CAUSE FOR THE IIPV WAS UNDETERMINED. THE PRODUCT ANALYSIS LAB DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. PRODUCT SURVEILLANCE CONTACTED THE NURSE AND PROVIDED THE RESULTS OF EVALUATION. THE NURSE STATED THAT THE PATIENT IS DOING WELL WITH THE NEW CYCLER AND SHE STATED THAT SHE WILL RE-EDUCATE THE PATIENT ON NOT TO BYPASS THE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DEVICE WAS SENT TO SERVICE. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP EMDR.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A HOMECHOICE DEVICE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) ISSUE WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 /DURING DRAIN CYCLE 5. THE ULTRAFILTRATION WAS 1757 ML. THIS IS AN OVERFILL EVENT.

    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 42 YR