BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO GARD6201 COMPATIBLE BLOODSET

    MDR report key: 1951146 · Received January 6, 2011

    Report

    Report Number
    6000001-2011-00093
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 5, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    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. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS COMPLAINT SHALL BE COMMUNICATED TO THE MANUFACTURING AREA AND QUALITY ASSURANCE RESPONSIBLE AT THE PLANT FOR THE PRODUCTION OF THE CODE MENTIONED IN THIS COMPLAINT TO ENSURE AWARENESS OF THIS COMPLAINT AND STRICT ADHERENCE TO RELEVANT REQUIREMENTS. FURTHERMORE, BAXTER SHALL KEEP MONITORING THESE EVENTS DURING QUALITY REVIEWS. 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 HAVE 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) A FLO-GARD COMPATIBLE BLOOD SET WITH DOUBLE FLEXIBLE DRIP CHAMBER THAT HAD A LEAK. ACCORDING TO THE REPORT, THE USER IDENTIFIED A LEAK AT THE BASE OF THE DOUBLE CHAMBER. THE CONDITION WAS REPORTED TO HAVE OCCURRED DURING PRIMING AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO 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
    1 FLO GARD6201 COMPATIBLE BLOODSET SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 08B13V509

    Patients

    Seq Age Sex Outcome Treatment
    1