BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082130 · Received May 22, 2008

    Report

    Report Number
    3004209178-2008-02737
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS OF THE DEVICE REVEALED THAT THE PUMP WAS STALLING INTERMITTENTLY. INSPECTION REVEALED A LARGE AMOUNT OF RESIDUE ON BOTH UPPER AND LOWER SHAFTS OF THE ROTOR MAGNET. THE FLUID FOUND IN THE MOTOR AND PUMP HEAD COMPARTMENTS CAUSED LOW RESISTANCE ACROSS THE M1 AND M2 FEEDTHRU. THE PUMP TUBE HOLES WERE A RESULT OF MECHANICAL WEAR.

    Additional Manufacturer Narrative · 1

    -FINAL DEVICE ANALYSIS OF THE PUMP REVEALED A RELIABILITY NON-CONFORMANCE - CORROSION. A RELATIVELY LARGE AMOUNT OF CORROSION, RESIDUE, AND FLUID WERE FOUND IN THE MOTOR AND PUMP HEAD COMPARTMENTS AND ON THE MOTOR GEARS. SOME OF THE TEETH WERE CORRODED AWAY ON GEAR WHEEL #3; GEARS #1 AND #2 HAD RESIDUE AND CORROSION SEEN ON THE GEAR SURFACES AND PINION. WEAR MARKS WERE SEEN ALONG THE TOPSIDE OF THE PUMP TUBE; TWO HOLES WERE WORN THROUGH THE PUMP TUBE NEAR BOTH THE INLET AND OUTLET AREA OF THE PUMP TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTOR STOPPED SEVERAL TIMES. THE CRITICAL ALARM WAS AUDIBLE. THE PATIENT WAS SEEN THE FOLLOWING DAY AND A 0.1 MCG SINGLE BOLUS WAS PROGRAMMED FOR ONE MINUTE. AFTER REPROGRAMMING, THE PUMP WAS WORKING IN CONTINUOUS MODE. THE PATIENT WAS SENT HOME. THE NEXT DAY, THE MOTOR STOPS WERE STILL OCCURRING. THE HCP WAS PLANNING TO ASPIRATE THE DRUG FROM THE PUMP, REFILL THE PUMP WITH SALINE AND PROGRAM A SINGLE BOLUS WHICH WAS LARGER THAN THE BOLUS PROGRAMMED THE DAY BEFORE. IF THE MOTOR STOPPED AGAIN, THE HCP PLANNED TO REPLACE THE PUMP. THE PUMP WAS USED TO DELIVER PRIALT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown