BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6181638 · Received December 16, 2016

    Report

    Report Number
    1828100-2016-00800
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 21, 2016
    Report Date
    August 30, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT VERIFIABLE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 · 1

    (B)(4). AS PER LOG REVIEW, THE ARTERIAL SMALL ROLLER PUMP WAS CONFIGURED TO PAUSE ON A LOW LEVEL ALERT. FREQUENT LOW LEVEL ALERTS STARTED TO OCCURRED AND CLEARED. AS A RESULT IT CAUSED THE PUMP TO PAUSE (0 RPM) BUT DID NOT STOP. THIS COMPLAINT IS RELATED TO (B)(4) MEDWATCH #1828100-2016-00797.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP STOPPED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THERE WAS NO DELAY IN THE PROCEDURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. PER CLINICAL REVIEW: THE SMALL ROLLER PUMP THAT WAS BEING USED FOR ARTERIAL PERFUSION. DURING CARDIOPULMONARY BYPASS, THE ROLLER PUMP SLOWED DOWN AND SOMETIMES TO ZERO (0)RPM IN PERIOD BUT THEN RETURNED TO ORIGINAL SET SPEED. THIS EVENT OCCURRED ALSO IN PREVIOUS CASES AND THE PUMP ALWAYS RETURNED TO THE SETTED SPEED IN A VERY SHORT TIME (SECOND). SOMETIMES IT HAD AN ERROR MESSAGE (E.G. BELTSLIP), BUT USUALLY NO MESSAGE WAS POSTED. AT TIMES, THE PUMP VIBRATED AND MADE A MECHANICAL NOISE BUT DID NOT ACTUALLY GO TO STOP MODE. THE SUBSIDIARY ASSOCIATE VISITED THE CENTER AND FOUND THAT THE HOSPITAL DOES NOT HAVE A REGULAR PREVENTIVE MAINTENANCE(PM) ON THEIR SYSTEM AND THE SUBSIDIARY ASSOCIATE ADMITTED THAT LACK OF REGULAR SERVICE COULD CAUSE THE PUMP ANOMALIES. THE SUBSIDIARY ASSOCIATE SPOKE TO THE PERFUSION TEAM ABOUT THEIR METHOD OF SETTING ROLLER OCCLUSION AND THEY ADMITTED THEY SET THE OCCLUSION ON THE "TIGHT SIDE" THAT COULD ALSO PLAY A ROLE. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THE PUMP WAS USED FOR THE PROCEDURE AND REMOVED FROM SERVICE AFTER THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM OBSERVED.

    Description of Event or Problem · 1

    THE PUMP WAS NOT CHANGED OUT DURING THE PROCEDURE, BUT WAS REMOVED FROM THE BASE AFTER THE CASE WAS OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833124 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801040

    Patients

    Seq Age Sex Outcome Treatment
    1