BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3180629 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10658
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 28, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT# N115773, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PUMP WITH CATHETER STILL ATTACHED TO PUMP OUTLET WAS RETURNED FOR ANALYSIS. A LEAK TEST WAS PERFORMED ON THE CATHETER BEFORE IT WAS SEPARATED FROM THE PUMP. NO LEAKING WAS SEEN. THERE WERE WHITE "FM" PARTICLES THAT FELT LIKE ¿SAND¿ ALL OVER THE SURFACE OF THE PUMP AND CATHETER. THE PUMP LOGS WERE GATHERED AND THERE WAS A MOTOR STALL RECOVERY INDICATOR PRESENT WHICH MEANS THAT THERE WAS A PAST MOTOR STALL AND RECOVERY SOME TIME IN THE PUMPS LIFE. THE PUMP SEPTUM WAS VISUALLY INSPECTED AND NO DAMAGE OR ANOMALIES WERE NOTED. THE SEPTUM WAS ALSO MONITORED FOR LEAKS THROUGHOUT THE ANALYSIS PROCESS. THE SEPTUM DID NOT LEAK DURING ANALYSIS. DISPENSE AND INFUSION ACCURACY TESTING WAS PERFORMED AND THE PUMP PASSED. DESTRUCTIVE ANALYSIS WAS DONE. SOME RESIDUE AND WEAR WAS NOTED THROUGHOUT THE PUMP BUT THIS WAS NOT UNCOMMON TO SEE IN A PUMP WITH AN IMPLANT TIME OF 62 MONTHS. NO PUMP PERFORMANCE ISSUE NOTED DURING ANALYSIS. PATENCY TESTING WAS PERFORMED WITH THE SC CATHETER STILL ATTACHED AS RECEIVED. NO LEAKING BETWEEN THE SC AND PUMP OUTLET WAS SEEN AND THE CATHETER WAS PATENT. THE CATHETER WAS REMOVED AND ANALYZED. THERE WERE WHITE "FM" PARTICLES FOUND ALL OVER THE SURFACE OF THE CATHETER SEGMENT AND PUMP. WHEN THE CATHETER WAS REMOVED FROM THE OUTLET PORT THE CATHETER HAD A "GRIT OR DIRT' LIKE FEELING TO THE SURFACE. THIS WHITE "FM" WAS NOT COLLECTED BECAUSE THERE WERE NOT ENOUGH PARTICLES TO COLLECT. VISUAL ANALYSIS NOTED THAT THE SC BOOT WAS PULLED BACK. TESTING SHOWED NO ISSUES WITH THE RETURNED CATHETER SEGMENT.

    Additional Manufacturer Narrative · 1

    FINAL PUMP ANALYSIS REVEALED NO ANOMALY FOUND. FINAL CATHETER ANALYSIS REVEALED NO SIGNIFICANT ANOMALY - THE INDENT IN THE SEAL DID NOT AFFECT INFUSION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERDOSE FOLLOWING A PUMP REFILL ON (B)(6) 2013. AS THE PATIENT LEFT THE CLINIC SHE BEGAN TO FEEL DROWSY. THE CLINIC CALLED THE PATIENT LATER THAT AFTERNOON AND THE PATIENT STATED THAT SHE FELT OVER-MEDICATED. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER). THE PATIENT CONTINUED TO DETERIORATE, BECAME LESS AROUSABLE AND WAS VERY SEDATED SO SHE WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT¿S PUMP DOSE WAS DECREASED AND THE PATIENT WAS ADMINISTERED NARCAN. THE CALLER STATED THAT THE PATIENT REBOUNDED BACK TO BASELINE WITHIN A DAY AND ¿RESOLVED PRETTY MUCH TO NORMAL¿ BUT SPENT 3 DAYS IN THE ICU. IT WAS NOTED THAT THE PATIENT¿S PAIN INCREASED AFTER THE PUMP WAS TURNED DOWN. THE CALLER STATED THAT THERE WAS NO POCKET FILL AND NO VOLUME DISCREPANCY. THE PATIENT¿S PUMP WAS PROGRAMMED BACK TO HER ¿NORMAL DAILY DOSAGE THAT SHE HAD PRIOR TO EVERYTHING¿ AND WAS FINE AFTER THAT. IT WAS ALSO NOTED THAT THE HEALTHCARE PROVIDER (HCP) WAS CONCERNED ABOUT THE INTEGRITY OF THE RESERVOIR REFILL SEPTUM AS ¿THERE¿S NOT A DIFFERENT FEEL FOR THE NEEDLE ENTERING THE SEPTUM RECENTLY¿. THE PUMP WAS LATER REPLACED ON (B)(6) 2013; HOWEVER, THE REPLACEMENT WAS ELECTIVE AS ¿THEY REPLACE THEM ALL AT FIVE YEARS¿THIS WOULD¿VE HAPPENED REGARDLESS OF ANY OF THESE ISSUES¿. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE, CLONIDINE AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AND APPEARED SEDATED. THE REPORTER STATED THAT THE CATHETER WAS PATENT AND NO BREAK OR OCCLUSION WAS SUSPECTED. IT WAS LATER REPORTED THAT THE PATIENT¿S SYMPTOMS HAD RESOLVED AND WAS RECEIVING EFFECTIVE THERAPY. IT WAS LATE REPORTED THAT THE PATIENT WAS LETHARGIC PRIOR TO ADMISSION TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279802 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| L| R