BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4180984 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19893
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 18, 2014
    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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PATIENT PROGRAMMER. PRODUCT ID: 8835, SERIAL# UNKNOWN, PRODUCT TYPE: PATIENT PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S PERSONAL THERAPY MANAGER (PTM) WAS REPORTEDLY UNRELIABLE IN DELIVERING BOLUS DOSES. THE PTM REPORTEDLY LOCKED THE PATIENT OUT WHEN THEY HAD NOT REACHED THEIR MAXIMUM DAILY BOLUSES, OR WHEN IT WAS WELL BEYOND THE LOCKOUT INTERVAL. THE PATIENT EXPERIENCED INCREASED PAIN WHEN THEY WERE UNABLE TO DELIVER A BOLUS. THEY WERE TO BE SEEN AGAIN BY THEIR PHYSICIAN TO READ THEIR PTM. REPORTS WERE RUN AND ALL OF THE LOCKOUTS SEEMED TO BE LEGITIMATE. THE PATIENT¿S PTM WAS SWAPPED OUT WITH ANOTHER ONE IN THE OFFICE AND THE ISSUES DID NOT RESOLVE. THE PATIENT WAS CONVINCED THAT THE PTM WAS NOT WORKING. THE PHYSICIAN WAS CONCERNED THAT THERE WAS A PUMP PROBLEM. LOGS WERE LATER PROVIDED. THEY REVEALED SEVERAL PATIENT ACTIVITY (PA) REQUESTS FOLLOWED IMMEDIATELY BY REJECTED PA REQUESTS. THESE OCCURRED ON (B)(6) (TWICE), (B)(6) 2014. A TECHNICAL REPORT WAS ALSO PROVIDED AND SHOWED THAT 231 BOLUSES WERE GIVEN AND 196 BOLUSES WERE DENIED BETWEEN (B)(6) 2014. SEVEN LOCKOUTS DUE TO ¿INTL¿ (INTERVAL) AND ONE LOCKOUT DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. ANOTHER LOCKOUT DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. TWO DUE TO ¿DRI¿ (DOSE RESTRICTION INTERVAL) AND TWO DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. TWO DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. THREE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. ONE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. THREE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. ONE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. ONE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. TWO DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. ONE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. THREE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. TWO DUE TO ¿DRI¿ AND FIVE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. ONE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. SEVEN DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. TWO DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. THREE DUE TO ¿DRI¿ AND NINE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. TWO DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. FOUR DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. SEVEN DUE TO ¿INTL¿ AND THREE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. A ¿4, SYS¿ ERROR WAS ALSO ENCOUNTERED ON (B)(6) 2014 WITH A ¿COMMUNICATION FAILURE¿ AND ¿INEFFECTIVE BOLUS¿ NOTED IN REFERENCE TO THIS. TWO DUE TO ¿DRI¿ AND SIX DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. IN RELATION TO THE ¿MAX¿ LOCKOUTS, IT WAS NOTED THAT THE PATIENT WAS ALREADY GIVEN FIVE BOLUSES WHICH WAS CONFIRMED IN THE TECHNICAL REPORT. AN UNEXPECTED LOCKOUT DUE TO ¿INTL¿ WAS NOTED ON (B)(6) 2014 AT 5:05. TWELVE ADDITIONAL DUE TO ¿INTL¿ AND FOUR DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. TEN DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014 WITH THE NOTE THAT THE PATIENT ONLY RECEIVED FOUR BOLUSES ON THAT DAY. THREE DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014, WITH THE NOTE THAT ONLY FOUR BOLUSES WERE GIVEN PRIOR TO THESE LOCKOUTS. TWO DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. SEVERAL DENIALS DUE TO UNSUCCESSFUL ACTIVATIONS WERE ALSO ENCOUNTERED. ANOTHER TECHNICAL REPORT SHOWED THAT 85 BOLUSES WERE GIVEN AND 26 BOLUSES WERE DENIED BETWEEN (B)(6) 2014. NINE BOLUS LOCKOUTS WERE DUE TO ¿MAX¿ ON (B)(6) 2014, (WHERE ¿MAX¿ IS THE MAXIMUM NUMBER OF BOLUSES ALLOWED PER DAY, MIDNIGHT TO MIDNIGHT). THESE FOLLOWED SIX BOLUSES THAT WERE SUCCESSFULLY GIVEN EARLIER ON THAT DAY. AT 00:01 ON (B)(6) 2014 ANOTHER LOCKOUT DUE TO ¿MAX¿ WAS ENCOUNTERED. TWO DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. TWO DUE TO ¿MAX¿ OCCURRED ON (B)(6) 2014. AS OF (B)(6) 2014, INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL INDICATING THAT THEY BELIEVED THE PUMP WAS FAULTY. THEY HAD TRIED THREE DIFFERENT PTM¿S AND PERFORMED COMPLETE INTERROGATIONS SEVERAL TIMES. THE BATTERIES WERE ALSO REPLACED MULTIPLE TIMES. THE ISSUE HAD NOT BEEN RESOLVED, AND THE PUMP WAS REPORTEDLY STILL NOT WORKING CORRECTLY. THE PUMP CONTAINED FENTANYL. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE THE CAUSE OF THE ISSUE. THE PATIENT'S OUTCOME WAS ALSO REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662215 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR