BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3116811 · Received May 16, 2013

    Report

    Report Number
    3004209178-2013-07795
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S NEW PERSONAL THERAPY MANAGER (PTM) WAS STOLEN AND SHE WAS USING THE OLD PTM. THE PTM THAT WAS STOLEN WAS PROGRAMMED TO DELIVER A BOLUS EVERY FOUR HOURS, FIVE TIMES A DAY. THE OLD PTM THAT THE PATIENT WAS CURRENTLY USING WAS CALIBRATED FOR EVERY SIX HOURS. THE PATIENT STATED SHE WOULD HAVE TO WAIT "SEVEN HOURS, EIGHT HOURS." THE PATIENT STATED THAT THE PTM WAS NOT RECOGNIZING THE PUMP INITIALLY; HOWEVER, THE PTM WAS CURRENTLY RECOGNIZING THE PUMP BUT WOULD GIVE THE PATIENT SPORADIC LOCKOUT INTERVALS; "IT'S JUST GIVING IT TO ME ONE VERY SEVEN HOURS, ONE EVERY FOUR HOURS, ONE EVERY EIGHT HOURS." THE PATIENT'S HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT TO HAVE THE MANUFACTURER SEND HER A NEW PTM BECAUSE THE ONE SHE WAS USING WAS NOT WORKING CORRECTLY. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT'S PTM WAS INITIALLY CALIBRATED JUST RIGHT WITH THE PUMP. THE PATIENT WAS RECEIVING THE CORRECT AMOUNT OF BOLUSES "EVERY FOUR HOURS FOUR TIMES A DAY." THE PATIENT THEN BEGAN TO RECEIVE THE SPORADIC LOCKOUTS. THE HCP RECALIBRATED THE PTM TO DELIVER A BOLUS FIVE TIMES A DAY. THE PATIENT'S PTM WAS THEN STOLEN AND THE PATIENT BEGAN USING THE OLD PTM. TROUBLESHOOTING WAS PERFORMED AND THE PTM THE PATIENT WAS CURRENTLY USING SHOWED 4 BOLUSES PER 24 HOURS WHILE HER PREVIOUS PTM WAS PROGRAMMED FOR 5 BOLUSES PER 24 HOURS. THE DEVICE SYSTEM ALSO DELIVERED BACLOFEN, BUPIVACAINE AND CLONIDINE. IT WAS LATER REPORTED THAT THE CALLER WANTED TO RESET THE PATIENT'S PTM. THE CALLER STATED THAT THE REFILL DATE WAS INCORRECT. THE REFILL DATE SHOULD HAVE SHOWED (B)(6) 2013 BUT INSTEAD SHOWED (B)(6) 2012. THE CALLER STATED "SOMETHING'S WRONG WITH THE PTM." TROUBLESHOOTING WAS PERFORMED AND AFTER SUCCESSFUL TELEMETRY THE PTM READ A NEW REFILL DATE OF (B)(6) 2013. THE PTM WAS ALSO PROGRAMMED TO DELIVER A BOLUS EVERY FOUR HOURS, FIVE TIMES A DAY. THE ISSUE WAS RESOLVED. IT WAS LATER REPORTED THAT THE PTM WAS NOW WORKING FINE AND THE PATIENT WAS ABLE TO GIVE HERSELF A BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218018 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1