BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202389 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04606
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 26, 2012
    Report Date
    April 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8840, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PHYSICIAN PRODUCT ID: 8709SC,# SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8840, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. HCP REPORTED A BRIDGE BOLUS WAS INCORRECTLY PERFORMED. HCP REPORTED TELEMETRY WAS INTERRUPTED WHEN UPDATING THE PUMP AND DOSING INFORMATION WAS UPDATED WITH CORRECT INFORMATION. HCP RE-ENTER ORIGINAL DRUG INFORMATION AND UPDATED THE PUMP THEN ENTERED NEW DRUG INFO, PROGRAMMED BRIDGE BOLUS AND UPDATED AGAIN. THIS ACTION RESOLVED THE ISSUE. NO PATIENT SYMPTOMS OR OUTCOME WERE REPORTED. THE SYSTEM USED TO DELIVER FENTANYL AND BUPIVACAINE (MARCAINE). IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301934 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR