BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK Y-TYPE BLOOD SETW/DUAL SCREEN FLT

    MDR report key: 1932605 · Received December 19, 2010

    Report

    Report Number
    6000001-2010-06014
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    FPB
    PMA / PMN Number
    K932301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A NO FLOW THAT OCCURRED ON ONE OF THE Y-SITE OF AN INTERLINK Y-TYPE BLOOD SET DURING PATIENT USE. THE SET WAS SPIKED PROPERLY. THE RN COULD SEE BLOOD IN THE SPIKE AND COULD BACK PRIME THE Y-SITE TO A CERTAIN POINT USING THE OTHER SPIKE BUT COULD NOT OBTAIN FLOW THROUGH THAT SIDE OF THE SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK Y-TYPE BLOOD SETW/DUAL SCREEN FLT FILTER, INFUSION LINE FPB BAXTER HEALTHCARE - CLEVELAND GR286682

    Patients

    Seq Age Sex Outcome Treatment
    1 BLOOD