BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)

    MDR report key: 7601851 · Received June 14, 2018

    Report

    Report Number
    1828100-2018-00311
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 22, 2018
    Report Date
    August 29, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) FOUND THAT THERE WAS A LOW RESISTANCE BETWEEN THE COMMON AND GROUND WIRES OF THE POWER CORD. RESISTANCE WAS MEASURING AT 11 OHMS WHEN INFINITE RESISTANCE WAS EXPECTED. THERE WAS ALSO OVERHEATING OBSERVED ON THE PLUG END OF THE POWER CORD. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    AS PER FIELD SERVICE REPRESENTATIVE (FSR) THERE WAS AN ALARM SOUNDING WHEN THE RED LIGHT WAS ILLUMINATED BUT THE USER FACILITY SILENCED THE ALARM.

    Additional Manufacturer Narrative · 1

    PER THE USER FACILITY, AFTER THE PROCEDURE THEY HAD THE RECEPTACLE INSPECTED AND WHEN THE UNIT WAS PLUGGED BACK IN THE RED ALARM LIGHT WAS NOT ILLUMINATED. THE FIELD SERVICE REPRESENTATIVE (FSR) VERIFIED THE REPORTED COMPLAINT. HE FOUND THE UNIT TO BE DRAWING 223/222 AMPS. AFTER UNPLUGGING ON ALL ALTERNATING CURRENT (A/C) SOURCES THE UNIT WAS STILL DRAWING TOO MUCH CURRENT. THE POWER CORD HAD A COMMON WIRE MEASURING A 30.22 OHM READING. HE REPLACED THE POWER CORD. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. THE SUSPECT PART WILL BE RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEATER COOLER HAD A RED LIGHT ILLUMINATED ON THE ISOLATION PANEL. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: DURING A CPB PROCEDURE ON (B)(6) 2018, THE HEATER COOLER WAS LEAKING CURRENT, THEREFORE THE OVER CURRENT MESSAGE (RED LIGHT) WAS NOTIFY THE PERFUSIONIST ON THE ISOLATION PANEL. THIS DID NOT AFFECT THE FUNCTION OF THE HEATER COOLER AND IT WAS USED THROUGHOUT THE CASE. THE PATIENT NOR THE USER WAS AFFECTED BY THE LEAKAGE OF CURRENT. THE PERFUSIONIST PULLED THE MACHINE OUT OF SERVICE AT THE END OF THE PROCEDURE AND THE FIELD SERVICE REPRESENTATIVE (FSR) EXCHANGED THE PLUG. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE DUE TO THE ISSUE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445243 SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING DWC TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 4415

    Patients

    Seq Age Sex Outcome Treatment
    1