BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSREAM PUMP 20 ML

    MDR report key: 7762928 · Received August 8, 2018

    Report

    Report Number
    8031062-2018-00505
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    July 16, 2018
    Report Date
    July 16, 2018
    Manufacturer
    MEDOS SARL
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00505. CONCLUSION: 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 #8031062-2018-00505. ADDITIONAL PATIENT AND INITIAL REPORTER INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MEDSTREAM PUMP (914200/(B)(4)) WAS WORKING SLOWER AND THE PATIENT WAS IN PAIN. THE PHYSICIAN BELIEVED THAT THE ISSUE MAY BE WITH THE CATHETER. AN MRI WAS SCHEDULED FOR (B)(6) 2018. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED; HOWEVER, A RESPONSE HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604039 MEDSREAM PUMP 20 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDOS SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention