BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4850288 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-11741
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Report Date
    May 22, 2015
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MISSED A REFILL. AN ALARM WAS HEARD BUT HAD NOT BEEN PERFORMED BY TELEMETRY. THE PATIENT HAD A CHANGE IN THERAPEUTIC EFFECT. THE PATIENT WAS LOW ON MEDICATION. THE LOW RESERVOIR ALARM WAS ON (B)(6) 2015 AND THE CRITICAL ALARM STARTED SOUNDING ON (B)(6) 2015. WITHDRAWAL SYMPTOMS WERE REPORTED. THE PATIENT WAS EXPERIENCING INCREASED PAIN. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S WITHDRAWAL SYMPTOMS INCLUDED WORSENING PAIN. THE REPORTED ALARM WAS CONFIRMED THROUGH TELEMETRY. THE ALARM THAT OCCURRED ON (B)(6) 2015 WAS REPORTED AS A NORMAL EARLY REPLACEMENT INDICATOR (ERI). A LOW RESERVOIR ALARM DID NOT OCCUR DESPITE THE PROGRAMMED RESERVOIR VOLUME BEING ABOVE THE PROGRAMMED LOW RESERVOIR ALARM VOLUME. IT WAS INITIALLY REPORTED THAT IT WAS UNKNOWN IF A LOW RESERVOIR ALARM OCCURRED, HOWEVER IT WAS LATER NOTED THAT THE LOW RESERVOIR ALARM WAS NOT ERRONEOUS. IT WAS INITIALLY REPORTED THAT IT WAS UNKNOWN IF THE PATIENT MISSED A REFILL, THEN IT WAS REPORTED THE PATIENT DID NOT MISSED A REFILL, HOWEVER LATER IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS A MISSED REFILL. THE EVENT WAS ATTRIBUTED TO THE PUMP. THE ISSUE WAS REPORTED TO BE A LOW RESERVOIR. IT WAS REPORTED THAT AN EMPTY RESERVOIR ALARM OCCURRED DESPITE THE PROGRAMMED RESERVOIR ALARM VOLUME BEING ABOVE ZERO VOLUME SUGGESTING AN ERRONEOUS EMPTY RESERVOIR ALARM. IT WAS UNKNOWN IF A PUMP RESET OCCURRED. A PUMP MEMORY ERROR (PME) DID NOT OCCUR. A STOPPED PUMP DID NOT OCCUR AND THE ALARM DID NOT OCCUR AFTER A MOTOR STALL. THE PUMP WAS NOT EXPOSED TO FREEZING TEMPERATURES DURING SHIPPING OR STORAGE. NO TROUBLESHOOTING, INTERVENTIONS OR OTHER ACTIONS WERE TAKEN TO MITIGATE OR RESOLVE THE EVENT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP WAS INFUSING DILAUDID (HYDROMORPHONE) AND MORPHINE (UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393953 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR