BEUDAMED
    FDA Adverse Event Summary report: N

    MIXER, OEM GENERAL

    MDR report key: 1785115 · Received January 8, 2010

    Report

    Report Number
    2020676-2009-00002
    Date Received
    January 8, 2010
    Date of Event
    December 7, 2009
    Report Date
    January 8, 2010
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISASSEMBLED BY DISTRIBUTOR TO INVESTIGATE THE CAUSE OF THE FAILURE. AWAITING THE DEVICE RETURN FROM DISTRIBUTOR TO COMPLETE INVESTIGATION. FOLLOW UP REPORT WILL BE SUBMITTED AFTER EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY AWI VIA EMAIL RECEIVED ON 12/10/09. DATE INCIDENT (B)(6) 2009. "CARDIO VASCULAR SURGERY WAS PERFORMED WITH APPLYING THE MIXER TO PCPS (PERCUTANEOUS CARDIOPULMONARY SUPPORT). DURING THE SURGERY, THE FLOW FROM THE MIXER SUDDENLY STOPPED. THE PHYSICIAN IN THE HOSPITAL REPORTED THAT THE PATIENT HAD BEEN UNCONSCIOUS FROM THE TIME THE SURGERY WAS PERFORMED, THOUGH THIS INCIDENT CAUSED THE PATIENT TO BE THE HYPOXIC FOR 2-3 MIN." INFORMATION FROM DISTRIBUTOR IS THAT THE PATIENT WAS UNCONSCIOUS PRIOR TO SURGERY. REFERENCE ATTACHMENT FOR FURTHER DETAILS OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIXER, OEM GENERAL MIXER BZR SECHRIST INDUSTRIES, INC. 3500CP-G NA

    Patients

    Seq Age Sex Outcome Treatment
    1