BEUDAMED
    FDA Adverse Event Death Summary report: N

    MS26 SYRINGE DRIVE

    MDR report key: 296695 · Received September 15, 2000

    Report

    Report Number
    9612511-2000-00009
    Event Type
    Death
    Date Received
    September 15, 2000
    Date of Event
    February 9, 2000
    Report Date
    September 15, 2000
    Manufacturer
    SIMS GRASEBY LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TO DATE THE DEVICE HAS NOT BEEN RETURNED TO SIMS GRASEBY LTD FOR FURTHER EVALUATION DESPITE SEVERAL ATTEMPTS TO REQUEST THE RETURN OF THE DEVICE. A FURTHER ATTEMPT HAS BEEN MADE DIRECT TO THE HOSP IN QUESTION IN SWEDEN TO OBTAIN THE DEVICE FOR FURTHER TESTING. CO'S UNDERSTANDING IS THAT THE DEVICE IS STILL AT THE USER FACILITY AND CO HAS REQUESTED CONFIRMATION OF THIS. IN ADDITION CO HAS MADE A DIRECT REQUEST TO THE HOSP FOR FURTHER INFO ON THE INCIDENT ITSELF AND THE RETURN OF THE DEVICE (SEE 2 ABOVE. THE SYRINGE DRIVER HAS BEEN TYPE TESTED TO THE REQUIREMENTS OF EN 60601-1-2:1993 FOR EMISSIONS AND IMMUNITY AND TO EN 55011:1991 FOR RF RADIATION. IN ADDITION TO THIS A TYPE TEST ON THE SYRINGE DRIVERS WAS CARRIED OUT AGAINST THE REQUIREMENTS OF THE RADIO TECH COMMISSION FOR AERONAUTICS SPEC RTCA/DO-160C. IN ALL INSTANCES. THE ORIGINAL INFO RECEIVED SUGGESTED THAT A POSSIBLE CAUSE MAY HAVE BEEN INTERFERENCE FROM A MOBILE TELEPHONE - CO HAS REQUESTED FURTHER EVIDENCE OF THIS FROM THE HOSP.

    Description of Event or Problem · 1

    BECAUSE OF PAIN, TREATMENT WITH AN INFUSION PUMP WAS STARTED 000209 AT 16.45 WITH HALDOL AND MORPHINE. THE PUMP WAS SET TO MORPHINE 10MG/ML, 4ML/24 HRS AND HALDOL 5MG/ML, 0,2ML/24 HRS, ADD WITH NACL 5,8ML FOR TOTAL OF 10ML. AT CONTROL THE NEXT DAY AT 10:00 THE PT WAS IN VERY BAD GENERAL CONDITION AND DIED BEFORE NOON. WHEN THE PUMP IS OPENED AFTER THE DEATH IT WAS FOUND THAT THE SYRINGE WAS EMPTY, WHICH WAS APPROXIMATELY 7 HRS EARLIER THAN EXPECTED. IT SHOULD BE ADDED THAT THE PT HAD BEEN TREATED WITH MORPHINE 30MG/24HR P.O. DURING FEB. 4-6TH WITH INCREASED DOSE TO 45MG/24HR P.O. FEB 7&8TH. THE CHOICE TO GO FOR PUMP ON FEB 9TH WAS DUE TO NAUSEA AND VOMITING. THE CHOSEN DOSE WAS NOT SIGNIFICANTLY HIGH AND THE PT MAY VERY WELL HAVE DIED FROM THE ORIGINAL DISEASE AND NOT BECAUSE OF AN EV. FAST INFUSION OF MORPHINE BY PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MS26 SYRINGE DRIVE INFUSION PUMP FRN SIMS GRASEBY LTD. MS26 SYRINGE DRIVER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death