BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 5444666 · Received February 18, 2016

    Report

    Report Number
    1828100-2016-00084
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Date of Event
    January 22, 2016
    Report Date
    March 10, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWB
    PMA / PMN Number
    K131618
    Removal / Correction Number
    1828100-05/04/12-010-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS RELATED TO MDR #1828100-2016-00085. THE FSR WAS UNABLE TO DUPLICATE THE REPORTED ISSUE WITH THE CARDIOPLEGIA (CPG) SET (WITHOUT CPG SOLUTION AND BLOOD) IN THE ROLLER PUMP. THE FSR DOWNLOADED THE DATA LOGS FOR EVALUATION BY THE MANUFACTURER. BASED ON THE DATA LOG ANALYSIS, THE MANUFACTURER CLINICAL SPECIALIST AND SUBJECT MATTER EXPERT (SME) INDICATE THAT THE ISSUE OCCURRED TWICE ON THIS DATE; ONCE DURING PRIME AND ONCE DURING BYPASS. THE FSR ADJUSTED THE BELT TENSION. PER THE CCP'S REQUEST, HE MOVED AND CONFIGURED THE CPG ROLLER PUMP TO THE VENT POSITION AND MOVED AND CONFIGURED THE VENT ROLLER PUMP TO THE CPG POSITION. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. NO PARTS BEING RETURNED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE CUSTOMER IS AWARE OVEROCCLUSION CAN CAUSE THE ISSUE. 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 PROCEDURE, THERE WAS A "BELT SLIP" AND AN "UNDERSPEED" ERROR MESSAGE OBSERVED ON THE ROLLER PUMP. THE ROLLER PUMP WAS IN CARDIOPLEGIA POSITION AND THE USER WAS USING AN 8:1 CARDIOPLEGIA SET. THE DEVICE WAS NOT CHANGED OUT, AS THEY LOOSENED OCCLUSION, PUMP WARMED UP AND THEN WORKED FINE FOR THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL SUMMARY ON (B)(6) 2016: INFORMATION FROM THE FIELD SERVICE REPRESENTATIVE (FSR) WAS ASSESSED AND THE DATA LOG ANALYSIS WAS REVIEWED. ACCORDING TO FSR, THE BELT SLIP AND UNDERSPEED MESSAGES OCCURED DURING PRIMING OF THE 8:1 CARDIOPLEGIA KIT. AN 8:1 KIT INDICATES TWO TUBING LINES ARE PLACED IN THIS ONE ROLLER PUMP. THE BLOOD LINE IS MUCH LARGER THAN THE DRUG LINE, AS THE BLOOD LINE HOLDS EIGHT TIMES MORE VOLUME THAN THE DRUG LINE. THIS CREATES A CHALLENGE WHEN OCCLUSION IS SET AS THE LARGER TUBING NEEDS TO BE OVEROCCLUDED IN ORDER FOR THE SMALLER TUBING TO BE ADEQUATELY OCCLUDED. THIS CAN LEAD TO OVEROCCLUSION AND CAN RESULT IN BELT SLIP AND UNDERSPEED MESSAGES IN 1.40 VERSION SOFTWARE PUMPS. THE USER LOOSENED THE OCCLUSION, DURING PRIME, AND WAS ABLE TO USE THE PUMP FOR THE PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASOCIATED BLOOD LOSS. THERE WAS NO HARM OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102335 TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1 DWB TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1