BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3140214 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08470
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8832, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S ERI WAS TWO MONTHS. THE PATIENT HAD BEEN ON MINIMUM RATE. THEIR PHYSICIAN WAS GOING TO TAKE THE REST OF THE MEDICATION OUT BECAUSE THE PATIENT ONLY HAD 1.8 ML¿S LEFT IN THE RESERVOIR. THEIR HEALTHCARE PROVIDER (HCP) WAS GOING TO PUT IN SALINE. THEIR HCP FURTHER NOTED THAT THEY ¿ENDED UP NOT DOING THAT BECAUSE THE PATIENT¿S ERI WAS IN TWO MONTHS SO THE DOCTOR TOLD THEM TO JUST SHUT OFF THE PUMP COMPLETELY SO THEY STOPPED THE PUMP¿. THEIR HCP PUT IN EVERYTHING THE SAME, THE SAME CONCENTRATIONS, AND THE RESERVOIR VOLUME THAT IT WAS PREVIOUSLY AT. THEY CHANGED THE LOWER RESERVOIR ALARM VOLUME TO 0 ML¿S, AND THEY CHANGED THE CRITICAL ALARM INTERVAL TO TWO HOURS AND THE NON-CRITICAL ALARM INTERVAL TO SIX HOURS. THE LOW RESERVOIR WAS SET TO 1.8 ML¿S. THEY CLICKED THE SILENCE ALARM CHECK BOX, BUT THE PRINTOUT DID NOT SHOW THAT THEY CLICKED ON THE SILENCED ALARMS. DISCUSSION REVEALED THIS WAS NORMAL AS THEY HAD SILENCED THE ACTIVE ALARM FOR LOW RESERVOIR, BUT THEY COULD NOT SILENCE FUTURE ALARMS. THE LOGS NOTED THAT ¿EMPTY RESERVOIR ALARM OCCURRED¿, AND BELOW IT SAID ¿LOW RESERVOIR ALARM OCCURRED¿. AN ALARM WAS ALSO NOTED TO HAVE OCCURRED IN THE PROCESS OF UPDATING THE PUMP. THE HCP NOTED THAT THEY HAD CHANGED THE RESERVOIR VOLUME FROM 1.8 ML TO 40 ML AND THEN CHANGED IT BACK TO 1.8 ML WITHOUT UPDATING THE PUMP. IT WAS THOUGHT THAT THIS TRIGGERED THE EMPTY RESERVOIR ALARM VOLUME. THE MEDICATIONS USED WITHIN THE SYSTEM WERE HYDROMORPHONE AND BUPIVACAINE.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER LATER REPORTED ON (B)(6) 2013 THE PATIENT DID NOT GET RELIEF WITH THE PUMP. THE PUMP ITSELF WAS AT END OF BATTERY LIFE. THE PHYSICIAN DID NOT WANT TO REPLACE THE PUMP DUE TO NO RELIEF. THE PHYSICIAN WANTED TO TURN THE PUMP OFF. THEY PUT THE PUMP IN ¿STOPPED¿ MODE. THE PUMP WAS ALARMING AND THE MANUFACTURER WAS CALLED AND INDICATED A CODE WAS NEEDED. THE PUMP WAS INSTEAD FILLED WITH PRESERVATIVE FREE NORMAL SALINE AND SET TO MINIMUM RATE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION, AND THEIR OUTCOME WAS NOTED AS ¿NO INJURY¿. AS OF (B)(6) 2013, THE PATIENT WAS SCHEDULED TO COME IN AT (B)(6) 2013 TO HAVE THEIR PUMP FILLED WITH NORMAL SALINE. THE PUMP LOGS CONFIRMED THE PUMP EARLY REPLACEMENT INDICATOR WAS IN 2 MONTHS AS OF (B)(6) 2013. ON (B)(6) 2013 THE HEALTHCARE PROVIDER NOTED THAT 4 ML WERE ASPIRATED WHEN 1.8 ML WERE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241259 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1