BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203128 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04825
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT REPORTED PRIMING BOLUS WITH UNKNOWN CATHETER VOLUME ON (B)(6) 2012 WITH SYMPTOMS. HCP REPORTED THE CATHETER VOLUME READ ON THE PUMP WAS 0.01ML. COMPANY REPRESENTATIVE REVIEWED THAT THE COMPANY DID NOT KEEP TRACK OF THE CATHETER LENGTHS. PHYSICIAN ASSISTANT (PA) DECIDED ON A LENGTH OF 69 CM (89CM-20CM) WHICH GAVE A VOLUME OF 0.152ML (69CM X 0.0022 ML/CM). THIS WAS THE CATHETER VOLUME TO PRIME AFTER ASPIRATING FORM CAP FOR CSF DRAWBACK. HCP USED COMPOUNDING PHARMACY FOR MENINGITIS AND WANTED TO CHECK THE COLOR OF THE CSF AS THE PATIENT HAD BEEN SICK. IT WAS REPORTED CSF WAS CLEAR. HCP STATED THAT AT THE TIME OF THE PUMP REPLACEMENT THE PATIENT WAS OVERDOSED BUT NO DETAILS WERE REPORTED ON THAT EVENT. SYSTEM USED TO DELIVER HYDROMORPHONE. FOLLOW UP HAS BEEN REQUESTED BUT NO ADDITIONAL INFORMATION WAS RECEIVED AS OF THE TIME OF THIS REPORT. A REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302280 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR