BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3843505 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09966
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A SIGNIFICANT PUMP MOTOR GEAR TRAIN ANOMALY RELATED TO CORROSION AND/OR WEAR AND/OR LUBRICATION. ANALYSIS FOR THE PUMP FOUND ANOTHER SIGNIFICANT PUMP MOTOR GEAR TRAIN ANOMALY RELATED TO STALL DUE TO SHAFT BEARING. ANALYSIS FOUND MOISTURE AND RESIDUE ON THE INSIDE OF THE INNER COVER, MOISTURE ON THE PUMPHEAD GEAR, OUTSIDE OF THE MOTOR CAN, ON THE TOP AND BOTTOM SIDE OF THE PUMPHEAD ROLLER ASSEMBLY, IN THE PUMPHEADS AND MOTORCAN'S BULKHEAD COMPARTMENT, ; CORROSION ON THE TOP SIDE OF GEAR WHEEL THREE. VISUAL INSPECTION OF THE UPPER SHAFT OF GEAR TWO, AFTER SOME OF THE RESIDUE WAS REMOVED, DETERMINED SHAFT WEAR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, LOT # J0058209R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IN THE PUMP LOGS SHOWED THAT A MOTOR STALL OCCURRED ON (B)(6) 2014 AT 6:55 P.M. WITH A RECOVERY ON (B)(6) 2014 AT 3:56 P.M. AND ANOTHER MOTOR STALL ON (B)(6) 2014 AT 7:18 P.M. WITH A RECOVERY ON (B)(6) 2014 AT 8:09 P.M. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SINGLE BEEP ALARM HEARD BY THE PATIENT. THE PATIENT REPORTED A RETURN OF SYMPTOMS. THE PATIENT WAS REPORTEDLY HAVING PROBLEMS WITH HER PUMP. THE PATIENT HAD A PUMP AND TWO STIMULATORS AT THE TIME OF REPORT. THE SYMPTOMS REPORTED WERE A RETURN OF PAIN AND A "CRAWLY FEELING" IN THE LEGS AND ARMS, INABILITY TO SIT STILL, AND OVERALL WEAKNESS. THE PUMP REPORTEDLY STARTED ALARMING ABOUT 5:00 A.M. ON (B)(6) 2014 AND THEN AGAIN AT 11 A.M., 4 P.M., 8 P.M., AND 9 P.M. THE PATIENT REPORTEDLY DID NOT HEAR THE ALARM AT ALL ON THE DAY OF REPORT. IT WAS REPORTED THAT THERE WAS A CONFIRMED MOTOR STALL ON (B)(6) 2014 AT 8:12 A.M. NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THERE WAS A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE ON (B)(6) 2014 AT 8:12 A.M. THE PATIENT REPORTEDLY WAS HEARING A CRITICAL ALARM AT THE TIME OF REPORT. THE PATIENT WAS REPORTEDLY BEING ADMITTED TO THE EMERGENCY ROOM WITH SYMPTOMS. THE PUMP WAS DELIVERING HYDROMORPHONE. IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED AND WAS REPLACED BY ANOTHER PRODUCT FROM THE SAME MANUFACTURER DUE TO THE "PUMP STOPPED BY EXCEED TUBE SET" MESSAGE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321968 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention