BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3902019 · Received February 24, 2014

    Report

    Report Number
    1828100-2014-00074
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 31, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. LAST PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED OCTOBER 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP WAS JAMMING UP. IN FIRST FOUR TO FIVE DELIVERY DOSES, THE PUMP WAS HAND CRANKED ONE REVOLUTION TO ALLOW FOR THE PUMP TO BE USED WITHOUT JAMMING. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT. PER THE CLINICAL REVIEW ON (B)(6) 2014: THE PERFUSIONIST (CCP) EXPERIENCED ABOUT FOUR TO FIVE EPISODES OF PUMP JAM WITH THE CARDIOPLEGIA ROLLER PUMP. A 4:1 CARDIOPLEGIA KIT WAS BEING USED, PER THEIR NORMAL PRACTICE. SET-UP OF THE CARDIOPLEGIA CIRCUIT WAS WITHOUT ISSUE AND ROLLER OCCLUSION WAS SET WITHOUT A PROBLEM. DURING DELIVERY OF FIRST FOUR TO FIVE DOSES, THE CARDIOPLEGIA PUMP WOULD JAM WHEN THE PUMP WAS FIRST STARTED AND ROLLER SPEED INCREASED. THE PUMP DISPLAYED "PUMP JAM" MESSAGE. THE CCP STATED THAT HE HAND CRANKED ONE REVOLUTION NAD THEN WAS ABLE TO USE THE PUMP, WITHOUT JAMMING, TO DELIVER THE DOSE. THE CCP STATED THIS DELAYED THE DELIVERY BY ABOUT 5 SECONDS FOR EACH DOSE. THE CCP STATED THE OPERATING ROOM WAS AT A TEMPERATURE OF SIXTY-TWO DEGREES FAHRENHEIT AND THE BLOOD TEMPERATURE IN THE CPB CIRCUIT WITH THIRTY TO THIRTY-TWO DEGREES CENTIGRADE. AFTER THE FIRST FOUR TO FIVE DOSES, THE CCP WOULD RUN THE PUMP A FEW RPM'S INTERMITTENTLY, AND THIS APPEARED TO PREVENT ANY FUTURE PUMP JAMS. ALL DOSES OF CARDIOPLEGIA WERE ABLE TO BE DELIVERED, IN THE VOLUME SPECIFIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND WITH NO DELAY OF THE ACTUAL SURGICAL PROCEDURE AS STATED BY THE CCP. THERE WAS NO ASSOCIATED BLOOD LOSS AND NO HARM OBSERVED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114466 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention