BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3031269 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08124
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE PRODUCT WAS NOT RETURNED TO BAXTER FOR EVALUATION, A LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A CONNECTION ISSUE DURING PERITONEAL DIALYSIS (PD) THERAPY. THE NURSE REPORTED THAT THE TITANIUM ADAPTOR DISCONNECTED AT THE BETA CAP RESULTING IN A BREAK IN THE LINE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133969 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 BETA CAP