BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3314823 · Received August 28, 2013

    Report

    Report Number
    1416980-2013-23198
    Event Type
    Malfunction
    Date Received
    August 28, 2013
    Report Date
    September 22, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER FOR THE LATE MEDICAL DEVICE REPORT: #(B)(4). THIS SUBMISSION IS LATE DUE TO THE RETROSPECTIVE REVIEW THAT WAS PERFORMED TO ADDRESS A CHANGE IN HOW BAXTER ASSESSES THE LIKELIHOOD OF HARM ASSOCIATED WITH SYSTEM ERROR ALARMS THAT COULD POTENTIALLY CHANGE THE PREVIOUS REPORTABILITY ASSESSMENT OF THE EVENT. THIS REPORT CAPTURES 8,977 FOR THE CONDITION OF AIR IN THE LINE WITHIN PRODUCT CLASSIFICATION CODE FKX. ONE ADDITIONAL RELATED REPORT HAS BEEN FILED FOR PRODUCT CLASSIFICATION CODE KDJ, PLEASE SEE COMPLAINT NUMBER (B)(4) FOR THE EVENT.

    Description of Event or Problem · 1

    THIS IS AN EXEMPTION REPORT FOR CASSETTES WHICH HAD AIR IN THE LINE. THIS REPORT COVERS BOTH CUSTOMER REPORTED AIR IN LINE EVENTS AND SYSTEM ERROR 2240 (AIR IN LINE) ALARM EVENTS FOUND DURING SERVICE. A SYSTEM ERROR 2240 ALARM ON A HOMECHIOCE DEVICE, INDICATES A POSSIBLE MALFUNCTION OF THE DISPOSABLE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422163 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1