BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM DRUG PUMP

    MDR report key: 7052125 · Received November 22, 2017

    Report

    Report Number
    8031062-2017-00015
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    September 5, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00015. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #8031062-2017-00015. BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. THERE ARE NO SIGNIFICANT SAFETY SIGNALS IDENTIFIED RELATED TO THIS REPORT BASED ON REVIEW OF COMPLAINT HISTORY. SINCE THE EVENT COULD NOT BE CONFIRMED AND THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿INTRATHECAL PUMP REFILLS, POCKET FILLS, AND SYMPTOMS OF DRUG OVERDOSE: A PROSPECTIVE, OBSERVATIONAL STUDY COMPARING THE INJECTED DRUG VOLUME VS. THE DRUG VOLUME EFFECTIVELY MEASURED INSIDE THE PUMP¿ BY PAOLO MAINO, MD; ROBERTO S.G.M. PEREZ, PHD; EVA KOETSIER, MD PUBLISHED NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE DOI: 10.1111/NER.12597, IT WAS REPORTED THAT PATIENT #1 HAD OVERDOSE SYMPTOMS AFTER MEDSTREAM PUMP REFILL WITH FENTANYL, TWICE, IN (B)(6) 2015. PER THE ARTICLE: ¿ONE COMPLICATION ASSOCIATED WITH THE REFILL PROCEDURE OF INTRATHECAL DRUG DELIVERY SYSTEMS (IDDSS) INCLUDE A ¿POCKET FILL,¿ WHICH IS THE INADVERTENT INJECTION OF THE DRUG INTO THE SUBCUTANEOUS SPACE SURROUNDING THE PUMP. THE PURPOSE OF OUR STUDY WAS TO ASSESS THE MEAN VOLUME DISCREPANCY BETWEEN THE INJECTED AND THE EFFECTIVE DRUG VOLUME INSIDE THE IDDS RESERVOIR AFTER REFILLS THAT DID NOT LEAD TO SIGNS OF OVERDOSE AND TO RECORD AT WHICH VOLUME DISCREPANCY SYMPTOMS OF OVERDOSE WERE NOTICED¿. THE MEDIAN VOLUME DISCREPANCY IN THE 20 ML IDDSS WAS 0.40 ML (IQR: 0.18¿0.61; 10THP: 0.0; 90THP: 0.74) WHEREAS IN THE 40 ML IDDSS THE MEDIAN VOLUME DISCREPANCY WAS 1.3 ML (IQR: 1.06¿1.74; 10THP: 0.81; 90THP: 2.2). SYMPTOMS OF OVERDOSE WERE OBSERVED AFTER 6 OUT OF THE 221 REFILL PROCEDURES. VOLUMES AT WHICH THE SYMPTOMS OF OVERDOSE AROSE WERE BETWEEN 1.15 AND 4.5 ML IN 20 ML IDDSS AND BETWEEN 2.08 AND 4.88 ML IN 40 ML IDDSS¿.. A VOLUME DISCREPANCY OF >1 ML IN 20 ML IDDSS AND OF >2 ML IN 40 ML IDDSS AFTER REFILL SHOULD BE REGARDED AS POTENTIALLY CONSEQUENTIAL WITH REGARD TO RISK OF OVERDOSE POSSIBLY CAUSED BY A POCKET FILL. IN CASE OF POTENTIALLY CONSEQUENTIAL VOLUME DISCREPANCIES, HOSPITALIZATION AND MONITORING IS RECOMMENDED TO PRECLUDE LATE OVERDOSE SYMPTOMS OUTSIDE THE HOSPITAL.¿ THE SYMPTOMS OF OVERDOSE STARTED BETWEEN 5 AND 90 MIN AFTER THE REFILL PROCEDURE. MOST FREQUENT SYMPTOMS OF OVERDOSE WERE SOMNOLENCE, RESPIRATORY DEPRESSION WITH DESATURATION (THE LOWEST VALUE WAS 82%), AND PINPOINT PUPILS. OTHER SYMPTOMS OF OVERDOSE WERE TREMOR, RIGIDITY, AND NAUSEA. IN ALL EXCEPT ONE CASE THE PATIENTS WERE TREATED WITH NALOXONE (BETWEEN 0.2 AND 1.4 MG). THIS LED TO IMMEDIATELY CLINICALLY RECOGNIZABLE ANTAGONIZATION OF THE SYMPTOMS OF OVERDOSE AND WAS ENOUGH TO NORMALIZE THE SPO2 AND RESPIRATORY RATE IN ALL PATIENTS. AS IN 2 PATIENTS THE SYMPTOMS OF OVERDOSE REAPPEARED AFTER ANTAGONIZATION, CONTINUOUS INFUSION OF NAXOLONE WAS STARTED (0.2 MG/ML AT A RATE OF 2¿4 ML/HOUR 50.4¿0.8 MG/HOUR) FOR UP TO THREE AND FOUR HOURS, RESPECTIVELY. IN TWO OF THE SIX CASES THE PATIENTS WERE HOSPITALIZED AND MONITORED OVERNIGHT. THE DECISION OF HOSPITALIZATION WAS NOT ONLY TAKEN ON THE BASE OF THE SEVERITY OF THE ADVERSE EVENTS BUT ALSO ON HOME CARE FACILITIES (LIVING ALONE, AGE, ANXIETY OF THE PATIENT). DURING THE HOSPITALIZATION, THESE PATIENTS WERE ALWAYS AROUSABLE, ORIENTED, HEMODYNAMICALLY STABLE, AND MAINTAINED OXYGEN SATURATION LEVELS CONSISTENT WITH THEIR BASELINE. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833139 MEDSTREAM DRUG PUMP DRUG INFUSION, IMPLANTABLE, PROGRAMMABLE LKK MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention