BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2792476 · Received October 9, 2012

    Report

    Report Number
    1828100-2012-01342
    Event Type
    Other
    Date Received
    October 9, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    TERUMO IS OUT OF STOCK ON TEMPERATURE PROBE/CLIPS FOR 3/8" TEMPERATURE PROBES. THIS PART IS PERTINENT TO MONITORING THE CARDIOPLEGIA TEMPERATURE. COMPETITOR SUPPLY ALSO RUNNING LOW. NO PATIENT INVOLVEMENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 12100

    Patients

    Seq Age Sex Outcome Treatment
    1