BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3051405 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05951
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE A BRIDGE BOLUS WAS NOT PERFORMED AT A REFILL ON (B)(6) 2013. THE REPORTER INDICATED THAT THE PATIENT WAS ON 500MCG/ML OF LIORESAL, WAS THEN REFILLED WITH 2,000MCG/ML BUT THE PUMP CONCENTRATION WAS NOT CHANGED TO THE 2,000MCG/ML CONCENTRATION AND THE BRIDGE BOLUS WAS NOT PERFORMED. ON (B)(6) 2013 THE PATIENT WAS IN THE HOSPITAL HAVING A GYNECOLOGICAL SURGERY AND SYMPTOMS/COMPLICATIONS NOT RELATED TO THE PUMP. THE PATIENT THEN STARTED HAVING SOME ISSUES WHICH LOOKED LIKE POSSIBLE OVERDOSE SYMPTOMS ALONG WITH THE OTHER COMPLICATIONS. THE HEALTHCARE PROVIDER (HCP) WENT TO THE HOSPITAL AND TURNED THE PUMP DOWN FROM 180MCG/DAY TO 80MCG/DAY, IN ORDER TO CLEAR THE PUMP AS A CAUSE 'OUT OF THE EQUATION.' AT THAT POINT WHEN THE DOSE WAS DECREASED TO 80MCG/DAY, THE HCP NOR THE REPORTER REALIZED THE PUMP WAS PROGRAMMED INCORRECTLY. PER THE REPORTER, IT WAS JUST THEN FIGURED OUT ON THE DAY OF THE REPORT, THAT THE BB WAS NEGLECTED UPON CONCENTRATION CHANGE AND THE PATIENT WAS STILL PROGRAMMED INCORRECTLY. REPORTER STATED THAT 'IN RETROSPECT THERE REALLY WAS AN ERROR WITH THE PUMP.' IT WAS FURTHER NOTED THAT IT WAS HARD TO KNOW WHAT SYMPTOMS WERE 'TRUE OVERDOSE' SYMPTOMS BECAUSE THERE WAS 'SO MUCH OTHER STUFF GOING ON.' IT WAS CALCULATED THAT THE REAL DOSE THE PATIENT WAS RECEIVING, BASED ON THE ACTUAL CONCENTRATION OF 2,000MCG/ML IN THE PUMP WAS 320MCG/DAY, AS THE PUMP WAS PROGRAMMED TO DELIVER 80MCG/DAY AND THE ACTUAL CONCENTRATION FILLED IN THE PUMP WAS 4X THE PROGRAMMED CONCENTRATION. THE HCP WAS PLANNING TO UPDATE THE PUMP TO CORRECT THE CONCENTRATION TO REFLECT WHAT THE PUMP ACTUALLY CONTAINS AND WHAT THE DESIRED DOSE SHOULD BE. THE MEDICATION BEING DELIVERED WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153316 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other