BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 3233991 · Received July 16, 2013

    Report

    Report Number
    1212122-2013-00007
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE, HOWEVER, THE COMPLAINT WAS CONFIRMED THROUGH CLINICAL REVIEW. WE HAVE BEEN INFORMED THAT THE DEVICE IS IN TRANSIT TO US AND WE WILL SUBMIT A FOLLOW-UP REPORT ONCE IT IS RECEIVED AND EVALUATED. THIS COMPLAINT WILL BE INCLUDED IN ASSOCIATES AWARENESS TRAINING. THE DEVICE HISTORY DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    OUR END USER HAS REPORTED THAT AT THE "END OF CASE STARTING TO BREAK DOWN AND DISCOVERED A COUPLE DROPS OF BLOOD ON THE ARTERIAL FILTER HOLDER." CLINICAL DISCUSSION: THERE WAS APPROXIMATELY 1-2 CC OF BLOOD LOSS DUE TO A LEAK FOUND AT THE INLET OF THE AF02. THE PRODUCT WAS NOT CHANGED OUT. THIS INCIDENT DID NOT HAVE ANY IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329958 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK DWF TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 71256-01 PL10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention