BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5244307 · Received November 23, 2015

    Report

    Report Number
    3004209178-2015-23298
    Event Type
    Injury
    Date Received
    November 23, 2015
    Report Date
    November 2, 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
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE SYSTEM DELIVERED MORPHINE 15 MG/ML IN FLEX MODE WITH BASAL RATE OF 0.145 MG/HR AND A DAILY DOSE OF 3.907 MG/DAY. THE PUMP HAD STALLED ON (B)(6) 2015. ANALYSIS OF THE PUMP REVEALED PUMP MOTOR GEAR TRAIN ANOMALIES. THESE INCLUDED CORROSION AND/OR WEAR AND/OR LUBRICATION AND STALL DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    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 HEALTH CARE PROVIDER VIA A REPRESENTATIVE REGARDING A PATIENT IN (B)(6) WHO WAS RECEIVING MORPHINE 15 MG/ML IN FLEX MODE WITH A BASAL RATE OF 0.145 MG/HR AND A DAILY DOSE OF 3.907 MG/DAY. THE INDICATION FOR USE WAS FOR PAIN THERAPY. AN ELDERLY PATIENT WAS BOOKED FOR A REFILL ON (B)(6) 2015 AND WHEN PUMP WAS INTERROGATED IT SHOWED "PUMP STOPPED". THE PATIENT WAS LAST REFILLED ON (B)(6) 2015. THE PROVIDED LOGS INDICATED A MOTOR STALL RECOVERY OCCURRED ON (B)(6) 2015 AT 22:55. MULTIPLE STALLS AND RECOVERIES OCCURRED WITH PERIODIC STOPPED PUMP PERIOD MAY EXCEED TUBE SETS AS WELL. THESE LOGS NOTED A STALL ON (B)(6) 2015, RECOVERY ON (B)(6) 2015, STALL ON (B)(6) 2015 STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2015, RECOVERY ON (B)(6) 2015, STALL LATER ON (B)(6) 2015, STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2015, RECOVERY ON (B)(6) 2015, A STALL LATER ON (B)(6) 2015, STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2015, RECOVERY ON (B)(6) 2015, LATER A STALL ON (B)(6) 2015, A STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2015, RECOVERY ON (B)(6) 2015, A STALL ON (B)(6) 2015, STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2015, RECOVERY ON (B)(6) 2015, A STALL ON (B)(6) 2015, STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2015, RECOVERY ON (B)(6) 2015, A STALL LATER ON (B)(6) 2015 AND STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON(B)(6) 2015. THE PUMP WAS REPORTED TO HAVE "CARRIED ON" THIS TYPE OF ACTIVITY. THE RESERVOIR VOLUME ON THE SESSION PRINTOUT NOTED 10 ML. THE PUMP WAS EMPTIED BY THE DOCTOR HOWEVER APPROXIMATELY 38 ML WAS WITHDRAWN. THE DOCTOR FILLED THE PUMP AGAIN WITH 10ML AND PUMP WAS UPDATED. THERE WAS NO CHANGE, A SINGLE BOLUS WAS GIVEN AND THERE WAS NO CHANGE. THE PATIENT DID NOT HERE THE ALARM GO OFF AND SO THE PATIENT DID NOT NOTIFY THE DOCTOR OF ANY PROBLEMS. THE CAUSE OF THE STALLS WAS UNKNOWN AS THE PATIENT WAS NOT EXPOSED TO MAGNETIC RESONANCE IMAGING OR A STRONG MAGNETIC FIELD. THERE WERE NO PATIENT SIDE EFFECTS OR WITHDRAW SYMPTOMS REPORTED. HOWEVER, IT WAS ALSO REPORTED THE PATIENT DID HAVE MORE PAIN THAN USUAL BUT NO WITHDRAWAL SYMPTOMS. THE ESTIMATED ELECTIVE REPLACEMENT INDICATOR WAS 4 MONTHS. ADDITIONAL MEDICATION WAS PRESCRIBED BY THE DOCTOR AND THE PATIENT WAS BOOKED TO SEE THE SURGEON FOR A PUMP REPLACEMENT. THE PUMP WAS REPORTED AS IMPLANTED BUT OUT-OF-SERVICE. AT THE TIME OF THE REPORT IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AND THE PATIENT WAS REPORTED AS ALIVE WITH NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS REPORTED AS NONE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT OBTAINABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON 11-27-2015 THE PUMP WAS RETURNED INDICATING THE PUMP WAS NOW EXPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773450 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention