BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 3896493 · Received May 16, 2014

    Report

    Report Number
    1828100-2014-00425
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K882758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPAIRED THE DRIVE MOTOR. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED. DUE DILIGENCE TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED ISSUE HAS BEEN UNSUCCESSFUL TO DATE. 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

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, HE FOUND WIRES BROKEN ON THE DELPHIN DRIVE MOTOR. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294604 TERUMO CENTRIFUGAL SYSTEM SARNS CENTRIFUGAL SYSTEM KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 164267

    Patients

    Seq Age Sex Outcome Treatment
    1