BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2864263 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11380
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    June 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8840 LOT#, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    APPROXIMATELY 2 MONTHS PRIOR, THE DRUG CONCENTRATION WAS INCORRECTLY PROGRAMMED TO 400 MCG/ML; IT SHOULD HAVE BEEN 480 MCG/ML WITH A PROGRAMMED DOSE OF 208.49 MCG/DAY. A BRIDGE BOLUS WAS NOT PERFORMED. WITH THE PUMP CONTAINING 480 MCG/ML AT THE PROGRAMMED DOSE, THE PATIENT WAS ACTUALLY GETTING 250.18 MCG/DAY. THEY REPROGRAMMED THE PUMP TO REFLECT WHAT WAS ACTUALLY BEING DELIVERED TO THE PATIENT. THE PATIENT HAD NO SIGNS OR SYMPTOMS RELATED TO THE EVENT. THE PATIENT OUTCOME WAS "NO INJURY". THE DEVICE SYSTEM WAS DELIVERING FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR