BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRASEBY 500 SYRINGE PUMP

    MDR report key: 3834401 · Received May 15, 2014

    Report

    Report Number
    2183502-2014-00305
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    March 21, 2014
    Report Date
    May 15, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT PUMP WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE PUMP FOUND CHIPS AND CRACKS IN THE PUMP'S OUTER CASE; HOWEVER, THESE CHIPS AND CRACKS WERE DETERMINED TO NOT HAVE ANY EFFECT ON THE PUMP'S PERFORMANCE. THE PUMP'S HISTORY WAS DOWNLOADED AND REVIEWED. THE REVIEW FOUND THAT TWO INFUSIONS WERE PROGRAMMED ON (B)(6) 2014; NO ISSUES WERE IDENTIFIED. FUNCTIONAL TESTING OF THE PUMP FOUND NO ISSUES. THE PUMP PASSED ALL TESTS WITHIN SPECIFICATIONS. EVALUATION AND TESTING OF THE DEVICE FOUND IT TO OPERATE AS INTENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) INDICATING THAT THE DEVICE WAS IN USE WITH PATIENT WHEN PATIENT PASSED AWAY. POLICE REPORTED TO (B)(6) THAT DEVICE OVER-INFUSED WHEN PATIENT EXPIRED AND WOULD LIKE THE PUMP TESTED. MEDICATION BEING INFUSED AT THE TIME WAS 8 MMOL MAGNESIUM SULFATE IN 100 ML OF SALINE OVER PERIOD OF 1 HOUR. NO SYMPTOMS WERE NOTED AND NO INTERVENTION WAS TAKEN PRIOR TO PATIENT EXPIRATION. OVER-INFUSION IS UNABLE TO BE CONFIRMED AS CAUSE OF PATIENT DEATH AT THIS TIME. FURTHER INFORMATION HAS BEEN REQUESTED; NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289689 GRASEBY 500 SYRINGE PUMP INFUSION, SYRINGE PUMP FRN SMITHS MEDICAL INTERNATIONAL LTD. 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death