BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 3924952 · Received June 24, 2014

    Report

    Report Number
    3005053560-2014-00005
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    TRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K050301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS OF EVENT RECEIVED ON (B)(6) 2014. PATIENT ARRIVED AT MRI WITH ALARIS PUMP, AND PATIENT SWITCHED TO MRIDIUM 3850 PUMP USING BYPASS INFUSION SET. HOSPITAL PERSONNEL ESTIMATED 500 ML INFUSION BAG WITH HEPARIN (25000 UNITS/500 ML FLUID) WAS USED AND APPROXIMATELY 330 ML REMAINED IN THE BAG FOLLOWING THE TRIP TO THE MRI. THE MRIDIUM 3850 INFUSION RATE AND VTBI SETTINGS WERE NOT PROVIDED TO IRADIMED, BUT THE ALARIS PUMP'S RATE PRIOR TO THE SWITCH-OVER WAS 23 ML/HR. THE MRIDIUM PUMP'S SETTING COULDN'T BE DETERMINED, AS THE EVENT LOG MEMORY BATTERY HAD BECOME DEPLETED PRIOR TO THE EVENT, AND THE EVENT LOG WAS EMPTY. THIS PUMP IS 7.5 YEARS OLD, AND THIS BATTERY HAD NOT BEEN REPLACED BY THE HOSPITAL TECHNICAL STAFF. APPROXIMATELY 10 MINUTES BEFORE THE MRI SCAN THE PUMP ALARMED WHEN THE BAG BECAME EMPTY. THE STAFF RESPONDED BY ADMINISTERING MEDICATION TO COUNTERACT THE HEPARIN, AND THE PATIENT WAS MONITORED UNTIL NORMAL BLOOD LEVELS WERE MAINTAINED. THE MRI SCAN WAS COMPLETED AND PATIENT RETURNED TO THE STROKE UNIT. NO PATIENT INJURY RESULTED, AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PUMP WAS RECEIVED AT IRADIMED ON (B)(4) 2014 AND AN EXAMINATION WAS MADE, AND NO PROBLEM WAS FOUND THAT COULD EXPLAIN THE EVENT. FOLLOW UP WAS DONE WITH THE HOSPITAL RISK MANAGER, AND SHE INDICATED THE HOSPITAL WAS FORMING A ROOT-CAUSE ANALYSIS TEAM TO DETERMINE THE EVENT CAUSE. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE HOSPITAL RISK MANAGER FOR ANY PROGRESS MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL RISK MANAGER. CONTACT WITH OTHER HOSPITAL STAFF (CLINICAL ENGINEERING) INDICATED IRADIMED NEEDS TO CONTACT THE RISK MANAGER, AND SHE WILL ANSWER ANY REMAINING QUESTIONS. ON (B)(6), THE HOSPITAL STAFF INTERVIEWED INDICATED THAT TRAINING OF THE USE OF THE PUMP MAY HAVE BEEN AN ISSUE. THE CAUSE OF THE EVENT MAY HAVE BEEN RELATED TO FAILURE TO CLOSE THE ALARIS SET MAIN CLAMP WHILE THE INFUSION WAS BEING PERFORMED. THIS WOULD HAVE ALLOWED A SECOND FLUID PATH OTHER THAN THAT BEING DELIVERED BY THE MRIDIUM PUMP. FOLLOW UP WILL BE MADE WITH THE HOSPITAL, AND A FOLLOW UP REPORT WILL BE PROVIDED WITHIN 45 DAYS OF THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    PRIOR TO AN MRI SCAN, THE HOSPITAL HAD REPORTED THAT WHEN THE PATIENT ARRIVED AT THE MRI, HE WAS BEING INFUSED BY ANOTHER INFUSION PUMP, AND A NURSE PERFORMED THE TRANSFER TO THE MRIDIUM PUMP. THE PATIENT HAD BEEN TRANSFERRED FROM THE STROKE UNIT OF THE HOSPITAL, AND WAS RECEIVING AN INFUSION OF HEPARIN USING A SOLUTION OF HEPARIN USING A SOLUTION AT A CONCENTRATION OF 50 UNITS/ML. THE MRIDIUM BYPASS INFUSION LINE WAS USED, WHICH BYPASSES AROUND THE PATIENT'S MAIN INFUSION LINE, WHICH REMAINS IN PLACE DURING THE MRI INFUSION. APPROXIMATELY 10 MINUTES PRIOR TO THE END OF THE MRI SCAN, THE PUMP ALARMED INDICATING THE BAG WAS EMPTY, AND AN OVERINFUSION OCCURRED. THE STAFF QUICKLY RESPONDED TO THE SITUATION, AND INITIATED ACTIONS TO PREVENT PATIENT INJURY. NO PATIENT INJURY RESULTED FROM THIS EVENT, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. PRELIMINARY INFORMATION INDICATES THE CLAMP ON THE PATIENT'S MAIN INFUSION LINE MAY NOT HAVE BEEN CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367937 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN TRADIMED CORPORATION 3850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention