BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5552265 · Received April 6, 2016

    Report

    Report Number
    3004209178-2016-06217
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Date of Event
    March 11, 2016
    Report Date
    April 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A DEVICE MANUFACTURER REPRESENTATIVE (REP) AND HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING HYDROMORPHONE 2 MG/ML AT 3.0052 MG PER DAY, BUPIVACAINE 4.9 MG/ML AT 7.3628 MG PER DAY AND CLONIDINE 10 MCG/ML AT 15.026 MCG PER DAY SINCE BEING REFILLED ON (B)(6) 2016 VIA AN IMPLANTABLE INFUSION PUMP FOR LUNG CANCER AND MALIGNANT PAIN. IT WAS REPORTED A PERSONAL THERAPY MANAGER (PTM) ERROR CODE OCCURRED, SPECIFICALLY AN ERROR CODE OF 8286 INDICATING AN EMPTY RESERVOIR. THE EVENT DATE WAS NOTED TO BE (B)(6) 2016. IT WAS NOT KNOWN TO THE REPORTER IF THE PATIENT WAS DUE FOR A REFILL. THE REP PLANNED ON CONTACTING THE PATIENT'S HCP TO NOTIFY THEM OF THE ALARM. NO SYMPTOMS WERE REPORTED INITIALLY. FURTHER INFORMATION WAS THEN RECEIVED FROM THE HCP. IT WAS REPORTED THERE WAS AN ERROR IN PLANNING THE REFILL. THE PREVIOUS REFILLS REPORTEDLY HAD EXCESS MEDICATION OF 13 TO 16 MILLILITERS SO THE HCP HAD PLANNED THE REFILL FOR THE NEXT WEEK. BECAUSE OF THE EMPTY PUMP, THE PATIENT EXPERIENCED PAIN WHEN SHE TRIED TO USE HER PTM TO RECEIVE A BOLUS IT DIDN'T WORK AS A RESULT. IN TERMS OF TROUBLESHOOTING PERFORMED, IT WAS NOTED THE REP WAS INVOLVED AND HAD LOOKED UP THE ALARM CODE. THE PATIENT WAS ADVISED TO TAKE ORAL MEDICATION ON SCHEDULE 24 HOURS A DAY AND WENT TO THE ED (EMERGENCY DEPARTMENT) TO HAVE A REFILL ON (B)(6) 2016 BECAUSE THE ORAL MEDICATION DID NOT COVER HER PAIN. FURTHER FOLLOW UP WAS THEN PERFORMED REGARDING THE REPORTED EXCESS VOLUMES AT PREVIOUS REFILLS. IT WAS REPORTED ON (B)(6) 2016 18 MILLILITER S WERE WASTED, ON (B)(6) 2016 16 MILLILITERS WERE WASTED AND ON (B)(6) 2016 13 MILLILITERS WERE WASTED. THE REASON FOR THE EXCESS MEDICATION WAS THAT THE HCP REFILLED THE PATIENT BEFORE THEY WERE OUT OF MEDICATION. THE EXPECTED VOLUMES PER THE PHYSICIAN PROGRAMMER FOR THE THREE FINDINGS WERE NOT SPECIFIED, HOWEVER IT WAS CLARIFIED THE HIGH VOLUMES WERE NOT UNEXPECTED. THEY HAD SCHEDULED THE PATIENT FOR REFILLS EVERY TWO WEEKS BECAUSE THE PATIENT COULDN'T TELL WHEN SHE WOULD BE DUE FOR A REFILL BASED ON HOW MANY BOLUSES SHE HAD USED. IT WAS A "SCHEDULING REASON" FOR THE VOLUMES RECOVERED AT THE PREVIOUS REFILLS, NOT A PUMP ISSUE. IT WAS ALSO REPORTED THE PATIENT WAS UNABLE TO CHECK THEIR PUMP FOR THE REFILL DATE IN REGARDS TO THE PREVIOUS REFILLS AND THERE BEING EXCESS MEDICATION. THEY HAD NOTICED THE EXCESS AND ADJUSTED THE REFILL DATE BY SCHEDULING THE PATIENT OUT LONGER, BUT THEN THE PATIENT HAD THE EMPTY RESERVOIR. SESSION DATA REPORTS WERE PROVIDED. THE PUMP WAS EXAMINED ON (B)(6) 2016 AT WHICH TIME LOW AND EMPTY RESERVOIR ALARMS WERE DISPLAYED. THE DOSE OF THE HYDROMORPHONE AT THE TIME OF INTERROGATION WAS LISTED AS 4.4990 MG PER DAY, THE BUPIVACAINE DOSE WAS 11.0226 MG PER DAY AND CLONIDINE DOSE WAS 22.495 MCG PER DAY. THE RESERVOIR VOLUME WAS 0.0ML PER THE REPORT AND IT INDICATED 46.0ML HAD "DISPENSED" SINCE UPDATE. THE REFILL DATE WAS LISTED AS (B)(6) 2016 AT MAX ACTIVATIONS. THE PUMP WAS THEN UPDATED THAT DAY WITH A 20 PERCENT INCREASE THE PATIENT'S SIMPLE CONTINUOUS DOSE. THEIR PA (PATIENT ACTIVATED) DOSE WAS INCREASED AS WELL. THE RESERVOIR VOLUME WAS UPDATED DURING THAT UPDATE TO 40.0ML AND THE REFILL DATE AT THE MAX ACTIVATIONS THEN DISPLAYED AS (B)(6) 2016. THEN ON (B)(6) 2016 AND (B)(6) 2016, THE PUMP WAS INTERROGATED AGAIN AND ANOTHER 20 PERCENT INCREASE IN THE PATIENT'S DAILY DOSE OCCURRED BOTH DAYS. THEIR PA DOSE WAS INCREASED BOTH DAYS AS WELL. AS OF (B)(6) 2016, THE PATIENT WAS RECEIVING THE SAME CONCENTRATIONS OF MEDICATIONS BUT WAS NOW RECEIVING 7.711 MG PER DAY OF HYDROMORPHONE, 38.855 MCG PER DAY OF CLONIDINE AND 19.0391 MG PER DAY OF BUPIVACAINE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A DEVICE MANUFACTURER REPRESENTATIVE (REP) AND HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING HYDROMORPHONE 2 MG/ML AT 3.0052 MG PER DAY, BUPIVACAINE 4.9 MG/ML AT 7.3628 MG PER DAY AND CLONIDINE 10 MCG/ML AT 15.026 MCG PER DAY SINCE BEING REFILLED ON (B)(6) 2016 VIA AN IMPLANTABLE INFUSION PUMP FOR LUNG CANCER AND MALIGNANT PAIN. IT WAS REPORTED A PERSONAL THERAPY MANAGER (PTM) ERROR CODE OCCURRED, SPECIFICALLY AN ERROR CODE OF 8286 INDICATING AN EMPTY RESERVOIR. THE EVENT DATE WAS NOTED TO BE (B)(6) 2016. IT WAS NOT KNOWN TO THE REPORTER IF THE PATIENT WAS DUE FOR A REFILL. THE REP PLANNED ON CONTACTING THE PATIENT'S HCP TO NOTIFY THEM OF THE ALARM. NO SYMPTOMS WERE REPORTED INITIALLY. FURTHER INFORMATION WAS THEN RECEIVED FROM THE HCP. IT WAS REPORTED THERE WAS AN ERROR IN PLANNING THE REFILL. THE PREVIOUS REFILLS REPORTEDLY HAD EXCESS MEDICATION OF 13 TO 16 MILLILITERS SO THE HCP HAD PLANNED THE REFILL FOR THE NEXT WEEK. BECAUSE OF THE EMPTY PUMP, THE PATIENT EXPERIENCED PAIN WHEN SHE TRIED TO USE HER PTM TO RECEIVE A BOLUS IT DIDN'T WORK AS A RESULT. IN TERMS OF TROUBLESHOOTING PERFORMED, IT WAS NOTED THE REP WAS INVOLVED AND HAD LOOKED UP THE ALARM CODE. THE PATIENT WAS ADVISED TO TAKE ORAL MEDICATION ON SCHEDULE 24 HOURS A DAY AND WENT TO THE ED (EMERGENCY DEPARTMENT) TO HAVE A REFILL ON (B)(6) 2016 BECAUSE THE ORAL MEDICATION DID NOT COVER HER PAIN. FURTHER FOLLOW UP WAS THEN PERFORMED REGARDING THE REPORTED EXCESS VOLUMES AT PREVIOUS REFILLS. IT WAS REPORTED ON (B)(6) 2016 18 MILLILITER S WERE WASTED, ON (B)(6) 2016 16 MILLILITERS WERE WASTED AND ON (B)(6) 2016 13 MILLILITERS WERE WASTED. THE REASON FOR THE EXCESS MEDICATION WAS THAT THE HCP REFILLED THE PATIENT BEFORE THEY WERE OUT OF MEDICATION. THE EXPECTED VOLUMES PER THE PHYSICIAN PROGRAMMER FOR THE THREE FINDINGS WERE NOT SPECIFIED, HOWEVER IT WAS CLARIFIED THE HIGH VOLUMES WERE NOT UNEXPECTED. THEY HAD SCHEDULED THE PATIENT FOR REFILLS EVERY TWO WEEKS BECAUSE THE PATIENT COULDN'T TELL WHEN SHE WOULD BE DUE FOR A REFILL BASED ON HOW MANY BOLUSES SHE HAD USED. IT WAS A "SCHEDULING REASON" FOR THE VOLUMES RECOVERED AT THE PREVIOUS REFILLS, NOT A PUMP ISSUE. IT WAS ALSO REPORTED THE PATIENT WAS UNABLE TO CHECK THEIR PUMP FOR THE REFILL DATE IN REGARDS TO THE PREVIOUS REFILLS AND THERE BEING EXCESS MEDICATION. THEY HAD NOTICED THE EXCESS AND ADJUSTED THE REFILL DATE BY SCHEDULING THE PATIENT OUT LONGER, BUT THEN THE PATIENT HAD THE EMPTY RESERVOIR. SESSION DATA REPORTS WERE PROVIDED. THE PUMP WAS EXAMINED ON (B)(6) 2016 AT WHICH TIME LOW AND EMPTY RESERVOIR ALARMS WERE DISPLAYED. THE DOSE OF THE HYDROMORPHONE AT THE TIME OF INTERROGATION WAS LISTED AS 4.4990 MG PER DAY, THE BUPIVACAINE DOSE WAS 11.0226 MG PER DAY AND CLONIDINE DOSE WAS 22.495 MCG PER DAY. THE RESERVOIR VOLUME WAS 0.0ML PER THE REPORT AND IT INDICATED 46.0ML HAD "DISPENSED" SINCE UPDATE. THE REFILL DATE WAS LISTED AS (B)(6) 2016 AT MAX ACTIVATIONS. THE PUMP WAS THEN UPDATED THAT DAY WITH A 20 PERCENT INCREASE THE PATIENT'S SIMPLE CONTINUOUS DOSE. THEIR PA (PATIENT ACTIVATED) DOSE WAS INCREASED AS WELL. THE RESERVOIR VOLUME WAS UPDATED DURING THAT UPDATE TO 40.0ML AND THE REFILL DATE AT THE MAX ACTIVATIONS THEN DISPLAYED AS (B)(6) 2016. THEN ON (B)(6) 2016, THE PUMP WAS INTERROGATED AGAIN AND ANOTHER 20 PERCENT INCREASE IN THE PATIENT'S DAILY DOSE OCCURRED BOTH DAYS. THEIR PA DOSE WAS INCREASED BOTH DAYS AS WELL. AS OF (B)(6) 2016, THE PATIENT WAS RECEIVING THE SAME CONCENTRATIONS OF MEDICATIONS BUT WAS NOW RECEIVING 7.711 MG PER DAY OF HYDROMORPHONE, 38.855 MCG PER DAY OF CLONIDINE AND 19.0391 MG PER DAY OF BUPIVACAINE. IT WAS ALSO NOTED THE PATIENT'S LAST REFILL HAD OCCURRED ON (B)(6) 2016. THE PATIENT HAD DILAUDID, 2.0MG/ML AT 3.0052MG/DAY, BUPIVACAINE, 4.9MG/ML AT 7.3628MG/DAY, AND CLONIDINE, 10.0MCG/ML AT 15.026MG/DAY, IN THEIR PUMP AT THAT TIME AGAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208615 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR