BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3160015 · Received June 10, 2013

    Report

    Report Number
    1416980-2013-14870
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE REPORTED PROBLEM AND SHOWED SEPARATION BETWEEN THE TUBING AND THE SPIKE COUPLER. FURTHER EXAMINATION REVEALED THE CAUSE OF THE REPORTED CONDITION WAS RELATED TO A MANUFACTURING ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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 INTERLINK SYSTEM Y-TYPE BLOOD SOLUTION SET'S TUBING SEPARATED FROM THE SPIKE AFTER THE UNKNOWN BLOOD SOLUTION BAG WAS HUNG. THE SPIKE REMAINED IN THE BAG; THE BLOOD LEAKED OUT OF THE BAG ONTO THE GROUND AND ONTO THE NURSE. THE NURSE WAS EXPOSED TO THE BLOOD BRIEFLY; APPROPRIATE CLEANING TECHNIQUES WERE UTILIZED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259405 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - AIBONITO UR13B07022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BLOOD SOLUTION BAG