BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 2770313 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01440
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED TO BAXTER; THEREFORE NO EVALUATION COULD BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT CORRECTED THE LEAK OF THE SET WITHOUT DISINFECTION AND ON (B)(4) 2012 WAS HOSPITALIZED WITH SYMPTOMS OF PERITONITIS. ADDITIONAL INFORMATION WAS RECEIVED: THE NURSE CONFIRMED THE PERITONITIS. THE CAUSE WAS A BREAK IN ASEPTIC TECHNIQUE, THE PATIENT HAS BEEN RETRAINED. THE PATIENT WAS TREATED WITH VANCOMYCIN (B)(6) CIPRINOL (2 X 200 MG) AND HAS RECOVERED.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A LOCKING TITANIUM ADAPTOR. THE NURSE RELAYED A REPORT FROM A HOME PATIENT (HP) WHO TWO DAYS EARLIER, DURING PREPARATION OF DIALYSIS SHE NOTICED A LEAK AT THE CONNECTION BETWEEN THE TRANSFER SET AND THE TITANIUM ADAPTOR. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD 11J24H35

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R TRANSFER SET