BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3912789 · Received May 14, 2014

    Report

    Report Number
    1828100-2014-00376
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 21, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00325. THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) WILL BE REPLACING THE CLIP. THE CUSTOMER DID NOT KEEP THE BROKEN CLIP TO RETURN TO THE MANUFACTURER FOR FURTHER EVALUATION. 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 (CPB) PROCEDURE, THE WHITE CLIP ON MANUAL DRIVE WHICH IS USED TO SECURE THE CENTRIFUGAL PUMP HEAD TO THE MANUAL DRIVE WAS BROKEN. THE PERFUSIONIST (CCP) HELD THE PUMP HEAD IN PLACE TO HAND CRANK UNTIL ANOTHER SYSTEM-1 WAS BROUGHT TO THE O/R. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW ON (B)(6) 2014: MDR 1828100-2014-00325 DESCRIBES AN ISSUE WHERE THE PERFUSIONIST (CCP) WAS NOT AWARE THAT THE SYSTEM-1 UNIT WAS BEING POWERED BY D/C POWER (BATTERY) AND THE BATTERY BECAME DEPLETED DURING CPB. THE ENTIRE SYSTEM-1 SHUT DOWN AND THE CCP USED A MANUAL DRIVE TO POWER THE CENTRIFUGAL PUMP HEAD. THE CLIP ON THE MANUAL DRIVE THAT SECURES THE PUMP HEAD WAS BROKEN AND THE CCP HELD THE PUMP HEAD IN THE MANUAL DRIVE AS THE CRANK WAS TURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288225 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CENTRIFUGAL DRIVE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 164268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention