BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST GAS BLENDER MODEL 3500

    MDR report key: 3820008 · Received May 14, 2014

    Report

    Report Number
    2020676-2014-00017
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS MADE AWARE OF REPORTED FAILURE THROUGH A MAUDE EVENT REPORT WITH THE VOLUNTARY REPORT NUMBER: (B)(4). THE FOLLOWING INFO WAS RECEIVED FROM THE HOSP. THE MIXER HAD JUST BEEN RECEIVED BACK FROM BEING SERVICED BY A THIRD PARTY. A PERFORMANCE VERIFICATION WAS NOT COMPLETED PRIOR TO THE MIXER BEING PLACED INTO CLINICAL USE. UPON PLACING THE PATIENT ON BYPASS, IT WAS IMMEDIATELY NOTED THAT THE PATIENT'S BLOOD WAS DARK, INADEQUATE OXYGENATION. THE PATIENT WAS REMOVED FROM THE MACHINE AND OXYGENATED MANUALLY UNTIL ANOTHER MACHINE WAS OBTAINED. NO ALARM ACTIVATED ON THE MIXER. THE MIXER WAS SENT A DIFFERENT THIRD PARTY SERVICING COMPANY FOR OVERHAUL. WHEN THE EVENT WAS REPORTED TO THE MFR THE MIXER HAD ALREADY BEEN RECEIVED BACK FROM THE THIRD PARTY SERVICE COMPANY AND WAS PLACED BACK INTO SERVICE, PER THE INFO PROVIDED BY THE HOSPITAL, THERE WAS NO INJURY TO THE PATIENT. THE DELAY IN SURGERY WAS MINIMAL AND THE PATIENT IS DOING FINE. MIXER S/N (B)(4) WAS NOT RETURNED TO THE MFR FOR EVAL. THE MIXER WAS MANUFACTURED IN OCTOBER 1984 AND IS 29 YEARS OLD. THE PROBABLE CAUSE FOR THE REPORTED FAILURE IS THAT THE DEVICE WAS NOT PROPERLY SERVICED.

    Description of Event or Problem · 1

    UPON INITIATING CARDIOPULMONARY BYPASS, THE PATIENT WAS OBSERVED TO NOT BE RECEIVING OXYGEN. THE ROOM SOURCE WAS CHECKED AND THE OXYGEN WAS BEING DELIVERED. THE SOURCE OF THE DEFECT WAS THE OXYGEN BLENDER LOCATED ON THE HEART-LUNG MACHINE. THE BLENDER WAS READING AS THOUGH IT WAS WORKING CORRECTLY, BUT BLOOD GAS AND OBSERVATION FOUND THE PATIENT WAS NOT GETTING SUPPLEMENTAL OXYGEN. THE MACHINE WAS IMMEDIATELY REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289026 SECHRIST GAS BLENDER MODEL 3500 MIXER, GENERAL BZR SECHRIST INDUSTRIES, INC. 3500CP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention