BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD/TMP

    MDR report key: 16831 · Received July 1, 1994

    Report

    Report Number
    16831
    Event Type
    Death
    Date Received
    July 1, 1994
    Date of Event
    June 24, 1994
    Report Date
    June 30, 1994
    Manufacturer
    TEXAS MEDICAL PRODUCTS, INC.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS 75-YR-OLD DIABETIC MALE WAS ADMITTED FOR REVISION OF AORTIC VALVE AND REPAIR OF ARTERIAL BLOCKAGE. HE WAS TAKEN TO SURGERY ON 6/23/94; ANESTHESIA WAS BEGUN AT 14:10 AND SURGERY BEGAN AT 15:30. THE FIRST 90 MINUTES OF THE CASE WAS RUN WITH AN ARTERIAL CANULA AND PRESSURES STAYING AROUND 300 MM. AFTER 90 MINUTES, AN AORTIC ARCH CANULA WAS USED WITH PRESSURES DECREASING TO AROUND 160 MM. AFTER ABOUT 5 1/2 HRS ON THE CARDIOPULMONARY BY-PASS MACHINE, THE AORTIC VALVE WAS REPLACED, AND THE PT HAD JUST REACHED NORMAL THERMIA, WHEN ALL OF A SUDDEN A TUBUING SEPARATION OCCURRED. THIS LINE SEPARATION OCCURRED DISTAL TO THE ARTERIAL LINE FILTER AT THE 3/8 X 3/8 LUER LOCK CONNECTOR. ALL OPEN LINES WERE IMMEDIATELY CLAMPED. THE SEPARATED TUBING WAS RECONNECTED AND TIE-BANDS APPLIED, TUBING WAS DE-AIRED AND THE PT WAS PUT BACK ON BY-PASS. REPEATED ATTEMPTS WERE MADE TO WEAN THE PT FROM BY-PASS, UNSUCCESSFULLY. BY-PASS WAS SUBSEQUENTLY SUSPENDED AND PT EXPIRED AT 0112, JUNE 24TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD/TMP EXTRACORPOREAL TUBE PACK DWE TEXAS MEDICAL PRODUCTS, INC. 28 BEX 168

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death