BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSTREAM PUMP 40 ML

    MDR report key: 7787042 · Received August 15, 2018

    Report

    Report Number
    8031062-2018-00507
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 16, 2018
    Report Date
    July 16, 2018
    Manufacturer
    MEDOS SARL
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00507. 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

    PRODUCT COMPLAINT # (B)(4). THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00507. ADDITIONAL PATIENT AND INITIAL REPORTER INFORMATION HAS BEEN REQUESTED; HOWEVER, A RESPONSE HAS NOT YET BEEN RECEIVED. (B)(6). THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS FOLLOW-UP MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2018-00507. THIS MDR IS BEING SUBMITTED TO CAPTURE THE ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 10, 2018: THE PUMP WAS IMPLANTED ON (B)(6) 2012. THE VOLUME OF MEDICATION IN THE PUMP AT THE TIME OF THE ALERT WAS 15.95ML. THE PATIENT DID NOT EXPERIENCE ANY OVERDOSE SYMPTOMS. THE DATE OF THE PATIENT'S LAST REFILL WAS (B)(6) 2018. REPORTEDLY, THERE WAS DIFFICULTY EXPERIENCED IN UNDERSTANDING THE CONCENTRATION OF THE DRUG. BACLOFEN IS BEING ADMINISTERED THROUGH THE PUMP. THE PUMP REMAINS IMPLANTED AND IS REPORTED TO BE RUNNING SMOOTHLY. MEDICAL INTERVENTION WAS NOT REQUIRED TO THE PATIENT. THE PATIENT HAS A CONCENTRATION OF 500¿G / ML BACLOFEN. FROM A CLINICAL POINT OF VIEW, LOW CONCENTRATIONS LEAD TO LESS EFFECT AT A DAILY DOSE OF 950¿G / 24H. SINCE THE ADJUSTMENT, THERE HAVE BEEN NO MORE PROBLEMS. THE PATIENT DID NOT EXPERIENCE ANY SIDE EFFECTS. THE PATIENT'S INFORMATION IS UNAVAILABLE. 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 (914201/UNK SERIAL NUMBER) WAS SHOWING THAT IT NEEDED TO BE REFILLED DESPITE THE FACT WAS NOT EMPTY. REPORTEDLY, THE PATIENT NEEDS MORE HIGH CONCENTRATION OF THE MEDICINE. NOTE: ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED; HOWEVER; A RESPONSE HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626102 MEDSTREAM PUMP 40 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDOS SARL

    Patients

    Seq Age Sex Outcome Treatment
    1