BEUDAMED
    FDA Adverse Event Death Summary report: N

    SARNS 7000 MODULAR PUMP, 230 V

    MDR report key: 77578 · Received March 20, 1997

    Report

    Report Number
    1828100-1997-00005
    Event Type
    Death
    Date Received
    March 20, 1997
    Date of Event
    February 21, 1997
    Report Date
    March 20, 1997
    Manufacturer
    3M HEALTH CARE, SARNS AND CDI PRODUCTS
    Product Code
    DWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN OPERATION, A BRIEF POWER INTERRUPTION CAUSED ALL OF THE PUMPS ON THE HEART LUNG MACHINE CONSOLE TO STOP. AFTER SWITCHING THE MASTER CIRCUIT BREAKER, THE PUMPS SPONTANEOUSLY RESUMED OPERATION AT THEIR PREVIOUS SPEEDS. SHORTLY AFTER THE PUMPS RESUMED FUNCTIONING, IT WAS REPORTED THAT THE LEFT VENTRICULAR VENT PUMP WAS GOING BACKWARDS AND PUMPING AIR INTO THE PT. AS SOON AS THE PERFUSIONIST REALIZED THIS, HE REMOVED THE TUBING FROM THE PUMP RACEWAY. THE PUMP WAS THEN REPLACED, THE PT COOLED AND PLACED IN HEAD-DOWN POSITION, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE DAY AFTER THE OPERATION, THE PT WAS EXAMINED BY A NEUROLOGIST AND ALL SIGNS APPEARED NORMAL. THREE DAYS AFTER THE OPERATION, THE PT SPIKED AN EXTREMELY HIGH BLOOD PRESSURE AND DIED. INSPECTION OF THE PUMPS AND BASE UNIT REVEALED NO VISIBLE ABNORMALITIES. ALL PUMPS AND BASE UNIT FUNCTIONED NORMALLY DURING ROUTINE OPERATIONAL TESTING. SPONTANEOUS RESTART WAS OBSERVED DURING VARIABLE VOLTAGE TESTING BUT IN NO INSTANCE DID SPONTANEOUS REVERSAL OF PUMP ROTATION DIRECTION OCCUR. NO IMMEDIATE CONCLUSIONS WERE DRAWN FROM THIS INITIAL INSPECTION AND TESTING. IN DEPTH INVESTIGATION OF THE DEVICE IS NOT POSSIBLE AT THIS TIME, AS THE HOSP HAS DECLINED TO RETURN THE DEVICE TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS 7000 MODULAR PUMP, 230 V PERFUSION ROLLER PUMP DWB 3M HEALTH CARE, SARNS AND CDI PRODUCTS 98-0702-0068-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R