BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3812128 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15496
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 19, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. AS THE TRANSFER SET 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.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN TRANSFER SET DISCONNECTED FROM THE PATIENT LINE DURING INITIAL DRAIN OF PERITONEAL DIALYSIS THERAPY, CAUSING THE PATIENT LINE TO DROP ON THE FLOOR. THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN ENDING THERAPY. THE PATIENT PLANNED TO RESTART THERAPY USING ALL NEW SUPPLIES. THERE WAS NO REPORT OF 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
    291893 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SET WITH CASSETTE| HOMECHOICE