BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5698230 · Received June 3, 2016

    Report

    Report Number
    3004209178-2016-10844
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    June 25, 2015
    Report Date
    April 26, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND OVERINFUSION WITH UNDETERMINED ROOT CAUSE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING 5 MG/ML BUPIVACAINE AT 1.6262 MG/DAY AND 15 MG/ML MORPHINE AT 4.878 MG/DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT MULTIPLE VOLUME DISCREPANCIES WERE REPORTED. ON (B)(6) 2015, THE EXPECTED RESIDUAL VOLUME WAS 4.9 ML AND THE ACTUAL RESIDUAL VOLUME WAS 4 ML. ON (B)(6) 2015, THE EXPECTED RESIDUAL VOLUME WAS 2.7 ML AND THE ACTUAL RESIDUAL VOLUME WAS 1 ML. ON (B)(6) 2016, THE EXPECTED RESIDUAL VOLUME WAS 3 ML AND THE ACTUAL RESIDUAL VOLUME WAS 2 ML. ON (B)(6) 2016, THE EXPECTED RESIDUAL VOLUME WAS 2.3ML AND THE ACTUAL RESIDUAL VOLUME WAS 1 ML. ALL THE VOLUME DISCREPANCIES REPORTED WERE WITHIN MANUFACTURER SPECIFICATION. NO SYMPTOMS WERE REPORTED REGARDING THE VOLUME DISCREPANCIES. IT WAS NOTED THAT THE HEALTH CARE PROVIDER WAS THINKING ABOUT REPLACING THE PUMP DUE TO THE DISCREPANCIES. IT WAS UNKNOWN IF A REPLACEMENT OCCURRED. ADDITIONAL INFORMATION WAS THEN RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE (REP) ON 06/02/2016. THE HCP HAD DECIDED TO REPLACE THE PUMP. AN ADDITIONAL DISCREPANCY WAS REPORTED ON AN UNKNOWN REFILL DATE, THE EXPECTED VOLUME HAD BEEN 3ML WHILE THE ACTUAL VOLUME FOUND WAS 0ML. IT WAS ALSO REPORTED THE PATIENT HAD EXPERIENCED OCCASIONS WHERE THEY WERE SYMPTOMATIC WITH OVERINFUSION. THE SPECIFIC SYMPTOMS WERE THAT THE PATIENT COULD NOT MOVE HER LEGS DUE TO THE BUPIVACAINE IN THE PUMP. THE EXACT TIMES THE PATIENT EXPERIENCED THE SYMPTOMS OR THEIR ONSET WAS NOT KNOWN. ADDITIONAL REFILL DATES THE PATIENT HAD INCLUDED (B)(6) 2016. THE PUMP WAS BEING REPLACED ON (B)(6) 2016. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S STATUS AFTER THE DEVICE WAS REMOVED WAS "RECOVERED WITHOUT SEQUELA." IT WAS NOTED THAT NO ROTOR OR DYE STUDY HAD BEEN PERFORMED. THE PUMP SYSTEM WAS DELIVERING MORPHINE 15MG/ML, BASAL RATE 0.180MG/HR AND BUPIVACAINE 5MG/ML, BASAL RATE 0.0600MG/HR IN FLEX DOSING AFTER PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352206 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention