BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202392 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04384
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8703WLL, LOT# P50194, IMPLANTED: (B)(6) 1996, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE PUMP REPLACEMENT THE SURGEON HAD CONNECTED THE NEW PUMP TO THE CATHETER WITHOUT FIRST PRIMING THE PUMP. THE SURGEON ATTEMPTED TO ACCESS THE CATHETER VIA THE SIDE ACCESS PORT, BUT WAS UNABLE TO ASPIRATE THE CATHETER. THE PHYSICIAN WAS NOT WORRIED ABOUT THE PATIENT HAVING A BREAK IN THERAPY AS A RESULT OF THIS. IT WAS DECIDED TO JUST RUN THE PUMP NORMALLY AND WAIT FOR THE WATER THAT WAS IN THE PUMP TO CLEAR THE TUBING. THE PHYSICIAN DECREASED THE SIMPLE CONTINUOUS DOSE. THE DRUGS BEING DELIVERED WERE HYDROMORPHONE (DILAUDID) AND BUPIVACAINE (MARCAINE).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW DETERMINED THIS EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3004209178-2012-03371. ANY ADDITIONAL INFORMATION REGARDING THIS EVENT WILL BE REPORTED IN THIS MANUFACTURER REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301020 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR