BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3192680 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10956
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8711, LOT# J0058136R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME IN FOR A ROUTINE PUMP REFILL. THEY WITHDREW THE APPROPRIATE AMOUNT, BUT WERE THEN UNABLE TO REFILL IT WITH 40CC. WHEN THEY HIT ABOUT 10CC THEY HAD RESISTANCE; WHEN THEY HIT 25CC THEY COULDN¿T GET ANY MORE IN THE PUMP. WHEN THE DOCTOR REMOVED HIS THUMB, ¿IT JUST KEPT COMING BACK LIKE IT WAS OVER PRESSURIZED OR SOMETHING¿. THEY DOCUMENTED THAT THE PUMP ONLY HAD 25CC IN IT AND PLANNED TO BRING THE PATIENT BACK. THERE HAD BEEN NO REFILL ISSUES IN THE PAST. THE PUMP WAS DELIVERING BUPIVACAINE AND MORPHINE. ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT THOUGHT THAT SHE WAS GOING THROUGH WITHDRAWAL AND THOUGHT THAT MAYBE HER PUMP WAS STOPPED. THIS HAD BEEN HAPPENING SINCE (B)(6) 2013. THE PATIENT WAS DOING BETTER ON (B)(6) 2013, BUT WAS STILL ¿NOT FEELING LIKE HERSELF¿. THE PATIENT HAD NOT HEARD ANY ALARMS. THE NEXT PUMP REFILL WAS DUE IN (B)(6) 2013. THEY WERE PLANNING TO CHECK THE PUMP LOGS. IT WAS LATER REPORTED THAT THE PUMP LOGS SHOWED THAT THE LAST UPDATE TO THE PUMP WAS DONE ON (B)(6) 2013. THE PUMP LOGS SHOWED A RESTART COMMAND. NO PUMP MOTOR STALLS WERE SEEN. THE PATIENT¿S SYMPTOMS WERE ¿GENERAL SCREAMING AND HOLLERING AND SHE COULD NOT KEEP HER LEGS STILL¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292020 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR