BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2882244 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12103
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND AN UNDER INFUSION AT MAXIMUM RATE ONLY. THE ROOT CAUSE WAS UNDETERMINED. THERE WERE NO ANOMALIES FOUND IN PUMP LOGS. DISPENSE ACCURACY TESTING WAS PERFORMED; THIS TEST CONSISTS OF TWO RATES TO BE PROGRAMMED INTO THE PUMP. THE FIRST RATE WAS AT A MAXIMUM RATE OF 24,000UL/DAY AND THE SECOND IS 300UL/DAY. THE MAXIMUM RATE DISPENSE TEST CONSISTENTLY FAILED AND WAS UNDER INFUSING ANYWHERE BETWEEN 19-30%. PARTIAL DESTRUCTIVE ANALYSIS WAS PERFORMED. SLIGHT GREEN COLOR WAS NOTED ON WHEEL 3 ALONG WITH WHAT LOOKED LIKE WHITE CRYSTALLIZED MATERIAL. THE NEXT STEP WAS TO TAKE AN OSCILLOSCOPE AND MEASURE THE MOTOR PULSE WIDTH AND AMPLITUDE TO RULE OUT A HYBRID ISSUE. THIS PUMP WAS PROGRAMMED AT 24,000UL/DAY RATE (IN THIS CASE PULSE EVERY 29.9MS) THEREFORE: 1/.0299=33.444 PULSES PER SECOND. THEN IF YOU TAKE 86400 (SECONDS IN A 24HR PERIOD) AND DIVIDE BY 0.0299=2889632.107 PULSES PER DAY. TAKE THE PULSES PER DAY 2889632.107 DIVIDE BY 24 ,000UL/DAY=120.40 WHICH WAS THE CALIBRATION CONSTANT OF THE PUMP. THE HYBRID WAS RULED OUT AS A CAUSE OF THE FAILED DISPENSE TEST BECAUSE PER WAVEFORM MEASUREMENT THE PUMP WAS BEING PULSED CORRECTLY BY THE HYBRID. NEXT, A 10 OHM RESISTOR WAS PLACED IN SERIES WITH ONE OF THE MOTOR WIRES TO MONITOR THE VOLTAGE WAVEFORM ACROSS THE RESISTOR; THIS ALLOWED A LOOK AT THE CURRENT FLOWING THROUGH THE MOTOR COIL. THIS STEP WOULD SHOW IF THE MOTOR WAS STALLING OUT WHICH COULD EXPLAIN THE UNDER INFUSION DURING THE DISPENSE TESTING. STALL PULSES HAVE A DISTINCTIVE SQUARE WAVE SHAPE. PUMP HEAD TORQUE TESTING WAS ALSO PERFORMED. THERE WAS NO ROOT CAUSE FOR THE DISPENSE TEST FAILURE AND THE INVESTIGATION WAS CONTINUING. ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALY. PARTIAL CATHETER WAS RETURNED AND ANALYSIS OF THE SC CONNECTOR FOUND A NON-SIGNIFICANT INDENT IN SEAL WHICH DID NOT AFFECT INFUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH AND DATE OF DEATH WAS UNKNOWN. THE DRUG DELIVERED VIA PUMP WAS FENTANYL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1