BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3002732 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03676
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 13, 2013
    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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. ACCESSORY: MODEL 8590-9, LOT# N307740, IMPLANTED: (B)(6) 2012. (B)(4). ASYMPTOMATIC FOR ANY OVERDOSE.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL PUMP ANALYSIS REVEALED NO ANOMALY FOUND - PUMP PASSED ALL INFUSION, NON-DESTRUCTIVE, AND FULL DESTRUCTIVE TESTING. DISPENSE TESTING AND ADDITIONAL 24 HOUR INFUSION TESTING PASSED SHOWING THAT THE PUMP WAS DISPENSING ACCURATELY. FINAL ANALYSIS OF THE CATHETER/SC CONNECTOR REVEALED NO SIGNIFICANT ANOMALY - DAMAGED AT EXPLANT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE HAD BEEN RESERVOIR DISCREPANCIES DURING THE "PAST FEW" PUMP REFILL APPOINTMENTS. THE EXPECTED RESERVOIR VOLUME (ERV) WAS 3.6ML AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 1.5ML. DUE TO A FAMILY EMERGENCY, THE PATIENT WAS FORCED TO POSTPONE HER PUMP REPLACEMENT UNTIL (B)(6) 2013. THE PATIENT STATUS WAS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PRESERVATIVE FREE SALINE WAS PUT INTO THE PUMP AT THE TIME OF REPLACEMENT. THE PATIENT WAS GOING INTO THE OFFICE THE WEEK OF (B)(6) TO HAVE DRUG PUT IN.

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED, ACTUAL RESIDUAL VOLUME 2 AND EXPECTED RESIDUAL VOLUME 11 (UNITS NOT REPORTED.) THE TWO PRIOR REFILLS HAD DISCREPANCIES "BUT NOT AS MUCH AS THE LAST REFILL." PATIENT WAS NOTED AS "ASYMPTOMATIC FOR ANY OVERDOSE," AND "STILL" REPORTED PAIN SYMPTOMS. THE DEVICE SYSTEM WAS USED TO INFUSE HYDROMORPHONE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104862 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Congenital Anomaly| R