BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3800538 · Received February 11, 2014

    Report

    Report Number
    1828100-2014-00055
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 17, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THIS COMPLAIN IS RELATED TO MDR #1828100-2014-00050. PER THE PERFUSIONIST, THERE WERE THREE TO FOUR PUMP JAMS REPEATEDLY PRIOR TO PUMP SHUT OFF. DURING A SECOND PUMP RUN, FIVE MORE TIMES BUT NOT REPEATEDLY. THE PUMP ONLY SHUT OFF ONE TIME. THIS UNIT WAS USED FOR THE REMAINDER OF THE PROCEDURE AND THEN CHANGED OUT. TROUBLESHOOTING ENTAILED RESETTING PUMP OCCLUSION AND CHECKING THE TUBING IN THE RACEWAY. THE PUMP CONTINUED TO JAM IF STARTED AT A LOW SPEED, BUT WHEN TURNED ON QUICKLY WOULD NOT JAM NO ERROR CODES WERE SEEN (BUT THE PUMP DID SHUT OFF, SO MAY HAVE MISSED ANY). AUDIBLE TONES, UNKNOWN. THERE HAD TO RETURN TO BYPASS TWO HOURS AFTER INITIAL ISSUES AND THE PROBLEM RETURNED WITH JAMMING BUT NOT SHUTTING OFF. THE PERFUSIONIST STATED THAT THE PATIENT WAS WEANED FROM CPB WITHOUT ISSUE AND THAT THE POST-OPERATIVE COURSE WAS WITHOUT INDICATION OF HARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP SHUT OFF. THIS PUMP WAS BEING USED FOR CARDIOPLEGIA. THE DEVICE WAS NOT CHANGED OUT, AS THE PUMP WAS USED FOR THE REMAINDER OF THE PROCEDURE AND THEN CHANGED OUT. THERE WAS A ONE TO TWO MINUTE DELAY UPON CROSS CLAMPING WHILE THE PUMP SHUT OFF. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89020 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1