BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170290 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10390
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 21, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REFILL THE HEALTHCARE PROVIDER (HCP) WAS ABLE TO ASPIRATE THE PUMP RESERVOIR, BUT WAS UNABLE TO FILL IT. TROUBLE SHOOTING WAS PERFORMED AND IT WAS DETERMINED THAT THE PUMP TUBING WAS PATENT AND THE NEEDLE WAS PATENT. THE HCP CALLED AGAIN THE SAME DAY AND WAS STILL UNABLE TO FILL THE RESERVOIR. TROUBLESHOOTING WAS AGAIN PERFORMED. THE PUMP WAS FLUSHED WITH PRESERVATIVE FREE NORMAL SALINE (PFNS) AND THE HCP WAS THEN ABLE TO SUCCESSFULLY FILL THE PUMP. THIS ACTION RESOLVED THE ISSUE. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED ON (B)(6) 2013. IT WAS NOTED THAT THE PUMP HAD REACHED NORMAL REPLACEMENT INDICATOR (ERI); HOWEVER, THE REPORTER STATED THAT THE CLINICIAN HAD SEVERAL ISSUES WITH ¿VAPOR LOCK¿ AND NOT BEING ABLE TO PROPERLY FILL THE PUMP AT REFILL TIME. IT WAS ALSO NOTED THAT THERE WAS ¿WHITE GUNK¿ FOUND INSIDE THE CONNECTION OF THE SUTURELESS CONNECTION (SC) CONNECTOR. IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED ONE YEAR EARLY DUE TO THE VAPOR LOCK ISSUE AND NOT BEING ABLE TO FILL THE PUMP BECAUSE THE VALVE WAS ACTUATED. THE CALLER STATED THAT IT WOULD TAKE SEVERAL TIMES TO GET THE PUMP TO BE ABLE TO BE FILLED. THE CALLER WAS ATTEMPTING TO DECOUPLE THE PATIENT¿S PERSONAL THERAPY MANAGER (PTM) FROM THE OLD PUMP AND RECOUPLE IT TO THE NEW PUMP. THE DEVICE SYSTEM ALSO DELIVERED BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271654 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention