BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2931882 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01058
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    February 17, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER (WIFE OF PATIENT) VIA A MANUFACTURER REPRESENTATIVE REPORTED THE NURSING FACILITY OVERDOSED THE PATIENT, THEN HE FELL AND BROKE HIS BACK. THE REPRESENTATIVE STATED THE OVERDOSE WAS CAUSED BY A PROGRAMMING ERROR. THE REPRESENTATIVE STATED THAT THERE WAS A LAWSUIT RELATED TO THAT; THEY WERE SUING THE NURSING FACILITY AND PHARMACY, BUT NOT THE DEVICE MANUFACTURER. THE EVENT OCCURRED ¿ABOUT 4 YEARS AGO¿. A PUMP REPLACEMENT WAS SCHEDULED, BUT THAT WAS UNRELATED TO THE EVENT. THE REPRESENTATIVE ASKED HOW FAR PUMP LOGS WENT BACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHARMACY HAD CHANGED THE CONCENTRATION OF THE MEDICATION AND THE PATIENT'S HEALTHCARE PROVIDER (HCP) DID NOT SEE IT. A REFILL HAD BEEN PERFORMED 23 HOURS PRIOR TO THE REPORT, BUT THE NEW CONCENTRATION AND DOSE WERE NEVER UPDATED, AND A BRIDGE BOLUS WAS NOT PROGRAMMER EITHER. IT WAS DETERMINED THAT THE OLD DRUG HAD ALREADY CLEARED THE SYSTEM SO A BRIDGE BOLUS WAS NO LONGER NECESSARY. AFTER REPROGRAMMING THE INFORMATION, THE HCP STATED THAT 'IT STILL DID NOT LOOK RIGHT,' AND IT WAS THOUGHT THAT SOMEONE 'MAY HAVE MADE A DOSE INCREASE WITHOUT THE HCP'S KNOWLEDGE OF IT'. THE PATIENT WAS NOTED TO HAVE BEEN ASYMPTOMATIC. THE MEDICATION USED WITHIN THE SYSTEM WAS INFUMORPH. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37819 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other