BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3851362 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10174
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY. AS RECEIVED, THE PUMP WAS EMPTY AND WAS PROGRAMMED TO STOP MODE. PUMP LOGS INDICATED A TUBE SET MESSAGE. PUMP LOGS SHOWED NO ANOMALIES. A SMALL BLEMISH IN THE FILL SEPTUM NEAR THE OUTER RING WAS VISUALIZED. NO LEAKING WAS FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8 731SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP MALFUNCTIONED. IT WAS PLANNED TO DISCUSS THE EVENT AT A MEDICATION ERROR MEETING. THE CAUSE OF THE EVENT WAS NOT REPORTED. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED SHOWING SYMPTOMS OF OVERDOSE 5-10 MINUTES AFTER A REFILL ON THE REPORT DATE. THE PATIENT STARTED OUT SLEEPY, THEN PASSED OUT OR WENT TO SLEEP A COUPLE OF TIMES AND DID NOT KNOW WHAT WAS GOING ON WHEN HE WOKE UP. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) AND THE PUMP WAS PROGRAMMED TO STOPPED MODE. AT THE TIME OF THE REPORT, THE PATIENT WAS IN PAIN BUT WAS AWAKE. IT WAS UNKNOWN IF THE PROCEDURE CAUSED THE PROBLEM. THE HEALTHCARE PROVIDER (HCP) ACCESSED THE PUMP AND PULLED OUT ALL OF THE MEDICATION. THERE WAS NO DISCREPANCY, SO A POCKET FILL WAS NOT SUSPECTED. THE MEDICATION WAS NOT CHANGED. THE PATIENT WAS ADMITTED TO THE HOSPITAL. PUMP LOGS WERE READ AND SHOWED NOTHING UNUSUAL. LOGS DID INDICATED THAT THE PUMP WAS UPDATED AT ¿13:45/13:46¿, WHICH WAS ASSUMED TO BE AT THE REFILL, AND AGAIN AT 14:37, WHICH WAS ASSUMED TO BE WHEN THE PUMP WAS PROGRAMMED TO STOPPED MODE. LOGS SHOWED THAT THE PATIENT GOT PERSONAL THERAPY MANAGER (PTM) BOLUSES ON THE REPORT DATE AT 7:06, 10:21 AND 13:25. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL, CLONIDINE AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED. AS OF 2014 (B)(6), THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, FOLLOWING A REFILL IN (B)(6) 2014, THE PATIENT WAS OVERDOSE AND HE EXPERIENCED OVERDOSE. IT WAS NOTED THAT THIS REFILL TOOK LONGER THAN USUAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS GIVEN NARCAN. IT WAS ASKED IF THE ISSUE WAS WITH THE PUMP OR THE PATIENT'S HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329536 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R