BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3081393 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06975
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS A PROGRAMMING ERROR IN THE OPERATING ROOM. IT WAS INDICATED THAT THE LABEL ON THE DRUG WAS INCORRECTLY INTERPRETED AND THEN THE PUMP WAS PROGRAMMED INCORRECTLY TO DOUBLE THE INTENDED DOSE. THE PUMP WAS THEN REPROGRAMMED TO CORRECT THE CONCENTRATION. THERE WAS NO PATIENT INJURY OR SYMPTOMS AND THE PATIENT DIDN¿T REQUIRE HOSPITALIZATION. IT WAS ALSO STATED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING DOUBLE THE INTRATHECAL DOSE THAT HE WAS PRIOR TO PUMP REPLACEMENT, DUE TO THE INCORRECT CONCENTRATION OF DRUG BEING INPUT DURING PROGRAMMING. THE PATIENT WAS SUPPOSED TO BE PROGRAMMED FOR 20MG/ML, BUT WAS ACCIDENTLY PROGRAMMED FOR 10MG/ML. THE INTENDED DAILY DOSE WAS 8.988MG, BUT THE PATIENT HAD BEEN RECEIVING 17.976MG/DAY FOR THE THREE DAYS PRIOR TO REPORT. IT WAS REPORTED THAT THE PATIENT HAD NOT HAD ANY ISSUES AND HAD BEEN DOING OKAY. IT WAS NOTED THAT THE PATIENT HAD BEEN ON HIGH DOSES IN THE PAST, SO HE 'APPARENTLY HAD QUITE A LOT OF TOLERANCE.' AT THE TIME OF REPORT, THE CONCENTRATION HAD BEEN CORRECTED AND THE PATIENT HAD BEEN REPROGRAMMED FOR 12.845MG/DAY WITH THE INTENT TO GET BACK TO 8.988MG/DAY IN THE FUTURE. THE DEVICE SYSTEM WAS INFUSING HYDROMORPHONE. TWO DAYS LATER, IT WAS REPORTED THAT THE DOSE WAS NOT EXACTLY THE SAME AS IT HAD BEEN PROGRAMMED. THE HEALTHCARE PROFESSIONAL (HCP) HAD PROGRAMMED A BOLUS DOSE TO 1.993, BUT THE VALUE AUTOMATICALLY CHANGED TO 1.990. DUE TO THIS, THE HCP COULDN'T GET THE PATIENT'S DAILY DOSE BACK TO WHAT IT WAS WITH HIS PRIOR PUMP. ONE WEEK AFTER THAT, IT WAS REPORTED THAT THE DRUG WAS 'WRONGLY' OR 'POORLY' LABELED. THE EVENT HAD REQUIRED THAT THE 'MEDICATION WAS REVISED.' THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180861 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR