BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2852811 · Received November 27, 2012

    Report

    Report Number
    1828100-2012-01482
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S TRAINED BIOMEDICAL ENGINEER (BIOMED) OPENED UP THE ROLLER PUMP AND HE NOTICED GREASE ON THE BELT AND PULLEYS. THE BIOMED WILL REPLACE THE BELT AND CLEAN THE PULLEYS BEFORE RETURNING TO CLINICAL USE. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, A "BELT SLIP" ERROR MESSAGE OCCURRED WHEN THE PERFUSIONIST TRIED OCCLUDING THE GUT WITH TUBING IN THE RACEWAY. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801041

    Patients

    Seq Age Sex Outcome Treatment
    1