BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1754979 · Received June 28, 2010

    Report

    Report Number
    1212122-2010-00067
    Event Type
    Malfunction
    Date Received
    June 28, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 3, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO RECEIVED THE ACTUAL DEVICE AND VISUAL INSPECTION CONFIRMED THAT THE BUBBLE TRAP WAS BROKEN. BASED ON THE INVESTIGATION, IT IS LIKELY THAT THE DAMAGE OCCURRED DURING SHIPPING. TERUMO HAS MADE A CHANGE TO THE PACKAGING REQUIREMENTS, ADDING A CARDBOARD PAD TO SEPARATE THE POUCHES WHICH WILL FURTHER PROTECT THE CONTENTS DURING SHIPPING. TERUMO BELIEVES THIS TO BE AN ISOLATED INCIDENT, WILL MONITOR FOR FUTURE ISSUES AND ASSOCIATE AWARENESS TRAINING WILL BE INCLUDED. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS LOT. THE DEVICE HISTORY RECORD 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

    THE USER FACILITY INFORMED TERUMO CARDIOVASCULAR THAT THE BUBBLE TRAP WAS CRACKED ON THE BOTTOM. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED OUT OF BOX AND THE EVENT DID NOT CAUSE A DELAY IN THE BEGINNING OF THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA LN30

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK