BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4210775 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37901
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT 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 DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) DURING AN UNKNOWN STEP OF PERITONEAL DIALYSIS THERAPY. IT WAS REPORTED THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT HAD ALREADY ENDED THERAPY AND DISCONNECTED THE SUPPLIES BEFORE CALLING. THE TROUBLESHOOTING THAT WAS PERFORMED DID NOT IDENTIFIED ANYTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE ALARM TO THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693829 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE