BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3971220 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24845
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE (HC) CASSETTE WAS LEAKING DURING THE PRIMING PHASE OF AUTOMATED PERITONEAL DIALYSIS THERAPY. THE HOME PATIENT (HP) WAS NOT CONNECTED AT THE TIME OF THE OBSERVED LEAK. A TECHNICAL SERVICE REPRESENTATIVE HELPED THE HP END THERAPY AND REMOVE THE CASSETTE. THE HP INDICATED THAT THERE WERE NO VISIBLE HOLES IN THE CASSETTE, ALL CONNECTIONS WERE STABLE, AND NO MOISTURE WAS FOUND IN THE CASSETTE DOOR. THE HP COULD NOT IDENTIFY THE LOCATION OF THE LEAK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446607 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE