BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3770723 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08080
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    July 31, 2013
    Report Date
    April 4, 2014
    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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709 , PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, PRODUCT TYPE: CATHETER. ADDITIONAL REVIEW OF THE EVENT DETERMINED IT HAD ALSO BEEN REPORTED IN MANUFACTURER REPORT #3007566237-2015-02097. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT WILL BE SUBMITTED UNDER THIS MANUFACTURER REPORT NUMBER. (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PUMP HAD UNDER-INFUSED. THE MOST RECENT VOLUME DISCREPANCY WITH REFILL ON (B)(6) 2014 NOTED THE EXPECTED RESERVOIR VOLUME (ERV) WAS 4.6 MILLILITERS (ML), HOWEVER, THE ACTUAL RESERVOIR VOLUME (ARV) WAS 9.2 ML. THE CAUSE OF THE DISCREPANCY WAS NOT KNOWN. ALL WAS FINE SINCE THE PUMP WAS IMPLANTED UP UNTIL (B)(6) 2013. THE PATIENT WAS IMPLANTED ON (B)(6) 2013 AND WAS SEEN IN (B)(6) FOR FOLLOW UP AND ALL WAS ¿OK.¿ THE REFILL IN (B)(6) 2013 WAS FINE. THE REFILL ON (B)(6) 2013 THE ERV WAS 7.5ML BUT THE ARV WAS 10ML, AT THE REFILL ON (B)(6) 2013 THE ERV WAS 7.5 ML AND THE ARV WAS 10.6ML. THE REFILL ON (B)(6) 2014 THE ERV WAS 4.6ML AND THE ARV WAS 7.2ML. THE PUMP WAS CONSISTENTLY OUT BY 3-4 ML. THE PATIENT SEEMED FINE WITH NO SYMPTOMS OF WITHDRAWAL OR UNDER DOSE. THE PATIENT HAD REPORTED A TENDERNESS AROUND THE CATHETER POSITION WHERE IT HAS BEEN TUNNELED/CATHETER TRACT BUT THERE WAS NO REDNESS. THIS WAS NOT BELIEVED TO BE ASSOCIATED WITH THE VOLUME DISCREPANCY. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. AT THE TIME OF THE EVENT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. A REPRESENTATIVE WAS TO ATTEND THE NEXT REFILL ON (B)(6) 2014 TO CHECK THE PROCEDURE. THIS DEVICE SYSTEM DELIVERED MORPHINE SULPHATE. IT WAS FURTHER PROVIDED THAT THE VOLUME DISCREPANCIES HAD BEEN HAPPENING FOR A WHILE AND THE PATIENT HAD ¿DETERIORATED¿ ALTHOUGH HAD GOTTEN SOME BENEFIT FROM THE PUMP. HOWEVER, THE PATIENT WAS NOT SHOWING ANY SIGNS OF UNDERDOSE. A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS DONE ON ¿4-13¿ WHICH CAME BACK CLEAR. IT WAS THOUGHT THAT PERHAPS AN X-RAY WOULD BE PERFORMED BUT THAT THIS WOULD NOT SHOW ANYTHING TO DO WITH THE PUMP. THE PATIENT HAD BEEN UNDER THE NEUROLOGIST TO SEE IF IT WAS MULTIPLE SCLEROSIS (MS) BUT THAT HAD COME BACK CLEAR AS WELL. ANOTHER MRI WAS TO BE SCHEDULED. A CATHETER ACCESS PORT STUDY WAS ALSO DONE ON (B)(6) 2013 WHILST IT WAS SAID THERE WAS RESISTANCE THE DYE WENT THROUGH THE CATHETER FINE. IT WAS UNKNOWN IF THE CATHETER CONNECTION WAS CHECKED AS THE PUMP APPEARED TO BE PUMPING. THERE HAD BEEN A SELECTION OF DRUGS IN THE PUMP AND NOT JUST ONE DRUG SINCE THE PUMP WAS IMPLANTED. THE NEXT REFILL WAS NOW SCHEDULED FOR (B)(6) 2014. THE PATIENT WAS CURRENTLY RECEIVING THERAPY FORM THE PUMP WITH THE DRUGS HE HAD AND NO EXPLANT WAS PLANNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REPORTED A VOLUME DISCREPANCY WAS DISCOVERED DURING A PUMP REFILL. THE ESTIMATED RESERVOIR VOLUME (ERV) WAS 5.1 MILLILITERS (ML) AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 10.2 ML. SURGICAL INTERVENTION HAD NOT OCCURRED, THE DIAGNOSTICS/TROUBLESHOOTING AND INTERVENTIONS WERE UNKNOWN. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. ON (B)(6) 2015, ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING ADDITIONAL VOLUME DISCREPANCIES AND CATHETER DATA. THE MEDICATION IN THE PUMP WAS MORPHINE SULPHATE 40 MGS/ML 3 MLS - 3.0 MG/ML DELIVERING SIMPLE CONTINUOUS MORPHINE 1.2491 MG/DAY PLUS SODIUM CHLORIDE 0.9% 37 MLS. THE ADDITIONAL VOLUME DISCREPANCIES WERE; (B)(6) 2014 ESTIMATED RESERVOIR VOLUME (ERV)= 4.6 ML AND ACTUAL RESERVOIR VOLUME (ARV)=7.2 ML, ON (B)(6) 2014 THE ERV=13.3 ML AND ARV=17 ML, ON (B)(6) 2014 THE ERV=7.5 ML, ARV=12.2 ML, ON (B)(6) 2014 THE ERV=7.5 ML, ARV=11.4 ML, ON (B)(6) 2015 THE ERV=8 ML, ON 12.1 ML, ON (B)(6) 2015 THE ERV=5.1 ML, ARV = 10.2 ML. THE NURSE CHECKED RECORDS, AND THE CATHETER HAD BEEN IMPLANTED SINCE (B)(6) 2013 AND THERE HAD BEEN NO CATHETER REVISIONS. THERE HAD BEEN NO FURTHER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249091 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1