BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIN SET. FOR LBL. BLD. DERIVW LL

    MDR report key: 1905156 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05145
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A BLOOD ADMINISTRATION SET WITH A LOOSE CAP. WHEN CONNECTING THE SET TO THE BLOOD WARMING COILS, IT BECAME JAMMED IN THE CONNECTOR AND THEN THE SCREW CAP CAME LOOSE AND ROLLED AROUND. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMIN SET. FOR LBL. BLD. DERIVW LL SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 10H23V467

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR