BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3193064 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10967
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 31, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, 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 PATIENT HEARD A CRITICAL ALARM FROM THE PUMP BUT THE ALARM WAS NOT CONFIRMED BY TELEMETRY. THE ALARM BEGAN THURSDAY (B)(6) 2013. THE PATIENT¿S LAST PUMP REFILL WAS (B)(6) 2013 AND THE NEXT REFILL WAS SCHEDULED (B)(6) 2013. THE PATIENT STATED THAT SHE TAKES ORAL MEDICATION AND HAD NOT NOTICED ANY DRASTIC CHANGES OR SYMPTOMS IN GENERAL. THE PATIENT REPORTED DOING FINE AND NOT IN PAIN. THE PATIENT CALLED HER HEALTHCARE PROVIDER (HCP) AND WAS WAITING TO HEAR BACK FROM THEM. IT WAS LATER REPORTED THAT THE CRITICAL ALARM WAS CONFIRMED BY TELEMETRY. THE ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME REACHED. THE PATIENT HAD STATED THAT THE ALARM WAS ¿SPORADIC¿. THE PATIENT WAS SEEN AT THE CLINIC BUT THE CLINIC DID NOT HAVE DRUG AVAILABLE TO REFILL THE PUMP. THE PATIENT WAS SEEN BY THE HCP AND THE HCP HEARD THE ALARM SOUND. THE PHYSICIAN PROGRAMMER SHOWED THAT 0ML OF DRUG WAS IN THE RESERVOIR; HOWEVER, UPON ASPIRATION THE HCP RECEIVED 11ML. THE CALLER CONFIRMED THAT THE HCP HAD EXPECTED 11ML. THE CALLER SATED THAT IT WAS POSSIBLE THAT THE RESERVOIR VOLUME WAS NOT UPDATED AT THE LAST REFILL. THE CLINIC UPDATED THE PUMP TO REFLECT THE REMAINING 11ML OF DRUG LEFT IN THE PUMP. THE PATIENT WAS NOT HAVING ANY THERAPY RELATED SYMPTOMS. IT WAS LATER REPORTED THAT THE PRINTOUT CONFIRMED THAT THE RESERVOIR VOLUME WAS UPDATED. IT WAS THOUGHT THAT THE HCP AT THE LAST REFILL POSSIBLY FORGOT TO UPDATE THE PUMP AFTER THEY PRINTED OUT THE PRINT REPORT; HOWEVER, THE PATIENT WAS LAST REFILLED AT THE HOSPITAL CLINIC SO THE OFFICE DID NOT HAVE A PHYSICIAN PROGRAMMER TO CHECK FOR THE SESSION DATE REPORT FROM THE PREVIOUS REFILL. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL AND WAS NOT EXPERIENCING ANY ADVERSE SIDE EFFECTS AND WAS RECEIVING EFFECTIVE THERAPY. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE 50MG/ML WITH A DOSE PER DAY OF 22.522MG AND BUPIVACAINE 30MG/ML WITH A DOSE PER DAY OF 13.513MG. IT WAS LATER REPORTED THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013. THE PATIENT WAS EXPERIENCING HEADACHES. THE PUMP WAS INTERROGATED AND NOTED TO HAVE FOUR ML IN THE RESERVOIR. THE PORT WAS ACCESSED WITHOUT DIFFICULTY AND FOUR ML OF FLUID WAS ASPIRATED. THE RESERVOIR WAS REFILLED WITHOUT DIFFICULTY. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013, FOR INTERMITTENT BEEPING OF THE PUMP. THE PATIENT WAS EXPERIENCING PAIN IN THEIR NECK AND HEAD IN SPASMS, LEFT FACIAL PALSY AND CHRONIC FACIAL PAIN. THE NECK PAIN WAS INDICATED AS A CHRONIC PROBLEM. THE CURRENT EPISODE STARTED MORE THAN ONE YEAR AGO AND WAS INTERMITTENT. THE PAIN WAS ON THE LEFT SIDE AND OCCIPITAL REGION DESCRIBED AS MILD CRAMPING AND ACHING. THE PAIN WAS AT A SEVERITY OF 1/10. ASSOCIATED SYMPTOMS WERE HEADACHES AND EYE PAIN. THE SYMPTOMS WERE AGGRAVATED BY BENDING. THE PUMP WAS INTERROGATED AND THE RESERVOIR VOLUME WAS ZERO. THE PLAN WAS TO HAVE THE PUMP REFILLED THE NEXT DAY. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013. THE PUMP WAS ACCESSED AND WAS FOUND TO HAVE 11ML OF MEDICATION IN THE RESERVOIR. THE PUMP WAS REPROGRAMMED. EVEN AFTER THE UPDATE THE PUMP ALARM WAS HEARD. THE PATIENT EXPERIENCED AN INCREASE IN PRESSURE IN HER FACE AND BELIEVED IT WAS DUE TO THE INCREASING ACTIVITY. THE PUMP WAS INTERROGATED AND THE REMAINING VOLUME WITHIN THE RESERVOIR WAS NOTED TO BE ZERO ML. THE RESERVOIR PORT WAS ACCESSED WITHOUT DIFFICULTY AND 11ML OF FLUID WERE ASPIRATED. THE RESERVOIR WAS THEN REFILLED WITH THE SAME 11ML. THE REFILL PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY. THE PUMP WAS PROGRAMMED TO PRESET SETTING OF DOSE PER DAY. IT WAS INDICATED THAT IT SEEMS THERE IS A MALFUNCTION WITH THE PUMP. PREVIOUS PROGRAMMING WAS REVIEWED AND WAS DONE CORRECTLY. UPON INTERROGATION OF THE PUMP THE PREVIOUS DAY IT REVEALED THERE WAS NO MEDICATION LEFT IN IT BUT THE HCP WAS ABLE TO ASPIRATE 11ML. THE ALARM THAT WAS HEARD WAS NOT THE SAME AS THE ALARM FOR A LOW VOLUME. AFTER THE UPDATE THE PUMP ALARM WAS HEARD. THE PUMP WAS REFILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294758 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR