BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIXER, OEM GENERAL

    MDR report key: 1652906 · Received March 26, 2010

    Report

    Report Number
    2020676-2010-00003
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    October 23, 2009
    Report Date
    March 26, 2010
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PERFORMED BY (B)(6). THE COMPLAINT WAS NOT VERIFIED AS REPORTED BY CUSTOMER. THE MIXER RAN TO MANUFACTURER SPECIFICATIONS. BIO-MED STATED THAT THE BLENDER HAD SUT OFF DURING THE PROCEDURE. THEY THINK THE PT WENT WITHOUT OXYGEN FOR QUITE SOME TIME. BIO-MED SENT COPIES OF HIS TEST READOUTS ALONG WITH THE BLENDER, WHICH SHOWED THE BLENDER WAS IN SPEC. CASE DILIGENCE: ON 10/19/09 CONTACTED CUSTOMER - PER (B)(6) THE BIOMED, THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PRODUCT MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY INJURY OR DEATH. NO BLOOD LOSS, BUT AS SOON AS THEY NOTICED THE COLOR OF BLOOD, THEY CHANGED OUT THE PRODUCT. COMPLAINT EVALUATION/INVESTIGATION. (B)(6) SERVICE TECHNICIAN TESTED AND RAN FUNCTIONAL TESTS ON THE UNIT, BUT COULD NOT DUPLICATE ANY ISSUES. THE ALARM TRIGGERED AND THE UNIT RAN ACCORDING TO THE MANUFACTURERS SPECIFICATIONS. REQUEST OF TEST DATA RESULTS AND PT OUTCOME HAS BEEN REQUESTED. WILL SEND FOLLOW-UP OF WITH THIS INFO WHEN RECEIVED.

    Description of Event or Problem · 1

    TERUMO CARDIO VASCULAR SYSTEMS (TCVS) INFORMED (B)(4) INDUSTRIES ON (B)(6) 2009. DURING A CARDIO PULMONARY BYPASS PROCEDURE, THE BLENDER HAD SHUT-OFF. THEY THINK THE PT WAS WITHOUT OXYGEN SOME TIME.

    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