BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSREAM PUMP 20 ML

    MDR report key: 8041326 · Received November 6, 2018

    Report

    Report Number
    8031062-2018-00509
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    September 29, 2018
    Report Date
    October 9, 2018
    Manufacturer
    MEDOS SARL
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INITIAL/FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00509. PATIENT INFORMATION WAS REQUESTED; HOWEVER, WILL NOT BE DISCLOSED IN (B)(6) FOR PRIVACY REASONS. DEVICE MANUFACTURE AND EXPIRATION DATES COULD NOT BE DETERMINED AS THE SERIAL NUMBER PROVIDED WAS INCORRECT. (B)(6). CONCLUSION: BASED ON THE INFORMATION, THE EVENT WAS CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE SERIAL PROVIDED IS INCORRECT. BASED ON THE REPORTED INFORMATION, THE ROOT CAUSE IS DUE TO MRI EXAMINATION. AS PER THE INSTRUCTIONS FOR USE (IFU), IT WAS INDICATED THAT "NON-CLINICAL TESTING HAS DEMONSTRATED THAT THE EXPOSURE OF A MEDSTREAM PROGRAMMABLE INFUSION PUMP TO AN MRI PROCEDURE MAY CAUSE A RESET EVENT THAT WILL STOP THE INFUSION AND ELICIT AN AUDIBLE ALARM OR BEEPING. THIS RESET EVENT DOES NOT CAUSE LOSS OF MEMORY DATA. UPON TERMINATION OF THE MRI PROCEDURE, INTERROGATE THE MEDSTREAM PROGRAMMABLE INFUSION PUMP WITH THE MEDSTREAM CONTROL UNIT TO OBTAIN THE PUMP¿S CURRENT STATUS. IF THE INFUSION PROGRAM HAS STOPPED, RESTART THE PROGRAM USING THE MEDSTREAM CONTROL UNIT. SUBSEQUENTLY TO THE MRI EXAMINATION, THE PUMP PROGRAM STOPS, THE PUMP ALARM BEEPS, THE FIRST PUMP INTERROGATION AFTER THE MRI EXAMINATION, AND EVERY FOLLOWING INTERROGATION REPORTS A PUMP HARDWARE FAILURE 11. A PUMP RESET EVENT REQUIRING CLOCK SYNCHRONIZATION MAY BE TRIGGERED. HARDWARE FAILURE 11 IS LINKED TO MRI. THE SYSTEM HAS BEEN RESET BY THE CUSTOMER, ACCORDING TO IFU INSTRUCTIONS, AND NOW THE DEVICE WORKS FINE. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN MRT PROCEDURE THE PATIENT¿S MEDSTREAM PUMP (914200/NKBF8M) EXPERIENCED A HARDWARE FAILURE 11; SHOWING A DRUG LEVEL INTEGRAL ERROR. THE FAILURE CAN BE REVISED AS IT IS A KNOWN EVENT AFTER AN MRI EXAMINATION. THE SYSTEM WAS REBOOTED AND IT WORKED FINE. THERE WERE NO CONSEQUENCES TO THE PATIENT. MORPHINE WAS BEING ADMINISTERED THROUGH THE PUMP TO TREAT CHRONIC PAIN. THE PATIENT DID NOT EXPERIENCE ANY WITHDRAWAL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882444 MEDSREAM PUMP 20 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDOS SARL

    Patients

    Seq Age Sex Outcome Treatment
    1