BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5792338 · Received July 13, 2016

    Report

    Report Number
    3004209178-2016-14178
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    April 5, 2016
    Report Date
    October 27, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THAT THE PUMP WAS OVERINFUSING BY MORE THAN 14.5% AT STANDARD TEST CONDITIONS AND TYPICAL THERAPEUTIC RATE (300 UL/DAY). THE ROOT CAUSE OF THE OVERINFUSION WAS UNDETERMINED. 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

    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

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

    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 HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL UNKNOWN MORPHINE 6 MG/ML AT 2.42 MG/DAY, COMPOUNDED BACLOFEN 320 MCG/ML AT 129.55 MCG/DAY, AND BUPIVACAINE 7 MG/ML AT 2.833 MG/DAY VIA AN IMPLANTED PUMP FOR NON-MALIGNANT PAIN. OVERINFUSION WAS ALLEGED AND VOLUME DISCREPANCIES WERE REPORTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS INCLUDING SWEATS, HEART RACING, AND NAUSEA. ON (B)(6) 2016 AT THE PATIENT'S REFILL, THE ACTUAL RESIDUAL VOLUME (ARV) WAS 0ML AND THE EXPECTED RESIDUAL VOLUME (ERV) WAS 4ML. THE REPORTER DID NOT BELIEVE THIS COULD BE RELATED TO A POCKET FILL. DISCREPANCIES ALSO OCCURRED AT PAST REFILLS INCLUDING ON (B)(6) 2016, THE ARV WAS 1ML AND THE ERV WAS 4ML. THE DRUGS WERE THE SAME AS THE CURRENT DRUGS IN THE PUMP. NO SYMPTOMS WERE REPORTED. THE RESERVOIR VOLUME INJECTED AT THE LAST REFILL WAS 20ML. A VOLUME DISCREPANCY ALSO OCCURRED ON (B)(6) 2016 AND THE ARV WAS 0ML AND THE ERV WAS 2ML WITH THE SAME DRUG AS CURRENT, NO SYMPTOMS, AND PUMP REFILLED WITH 20ML. THE HCP SAID THEY MAY PERFORM A DYE STUDY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THE PUMP WAS REPLACED ON (B)(6) 2016 FOR EXPECTED END OF SERVICE (EOS). THE PUMP WAS GOING TO BE SENT BACK FOR ANALYSIS. IT WAS ALSO INDICATED THAT AT THE REFILL ON (B)(6) 2016, THE PUMP WAS "NEARLY EMPTY"; ERV WAS 5.3ML AND ARV WAS 2.1ML. IT WAS NOTED THE LOW RESERVOIR ALARM VOLUME WAS ADJUSTED FROM 2ML TO 5ML. A DYE STUDY WAS PERFORMED ON (B)(6) 2016 AND WAS NORMAL. AT THE PUMP REPLACEMENT ON (B)(6) 2016, THE ERV WAS 12.1ML AND ARV WAS 9ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445397 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention