BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSREAM PUMP 20 ML

    MDR report key: 7806636 · Received August 22, 2018

    Report

    Report Number
    8031062-2018-00508
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 23, 2018
    Report Date
    July 24, 2018
    Manufacturer
    MEDOS SARL
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00508. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 17, 2018. THE PHYSICIAN MISSED THE PLANNED REFILL DATE, IT WAS DONE BY THE NURSES ON (B)(6) 2018 AND DIFFICULTY WAS EXPERIENCED. REPORTEDLY, THE NEEDLE OF THE REFILL KIT DID NOT STAY IN THE REFILL PORT, CAUSING APPROXIMATELY 9/10ML OF DRUG TO BE INJECTED IN THE PUMP POCKET. THE PATIENT¿S LAST REFILL DATE WAS (B)(6) 2018. MORPHINE, 1.4MG/24H, WAS BEING ADMINISTERED THROUGH THE PUMP. THERE WAS A MINIMAL INCREASE IN PAIN AND THE PATIENT WAS VERY ATTENTIVE. THE PATIENT WAS REPORTED TO BE A 6 ON THE VISUAL ANALOG SCALE OF PAIN, OTHERWISE A 3. THE PATIENT WAS SYMPTOMATIC, REPORTING ITCHY SKIN AROUND THE PUMP AND LIGHTHEADEDNESS. THE PHYSICIAN INTERVENED AND EXTRACTED THE DRUG THAT HAD BEEN WRONGLY INJECTED IN THE POCKET. THE NURSES CONFIRMED THAT THE PATIENT WAS FEELING BETTER AFTER A COUPLE OF MINUTES. THE PUMP WAS LEFT HALF REFILLED AND A NEW REFILL DATE WAS CHOSEN FOR A LATER DATE IN ORDER TO MINIMIZE DISCOMFORT TO THE PATIENT. BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00508. ADDITIONAL PATIENT, EVENT, AND INITIAL REPORTER INFORMATION HAS BEEN REQUESTED; HOWEVER, A RESPONSE HAS NOT YET BEEN RECEIVED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT HALF OF THE VOLUME OF MEDICATION WENT STRAIGHT TO A PATIENT DURING THE REFILL OF A MEDSTREAM PUMP (914200/NMBJ7P). THE PATIENT FELT A BIT UNWELL AT THE BEGINNING DUE TO THIS ISSUE, BUT WAS REPORTED TO BE OKAY. THE PHYSICIAN WAS CONSULTED. NOTE: ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, A RESPONSE HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646768 MEDSREAM PUMP 20 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDOS SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention