BEUDAMED
    FDA Adverse Event Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 3769655 · Received April 9, 2014

    Report

    Report Number
    1212122-2014-00002
    Date Received
    April 9, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1212122-04/04/2014-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO CONFIRMED THE ISSUE THROUGH A REVIEW OF THE DHR RETENTION LABELS AND EVAL OF PRODUCT REMAINING IN OUR CONTROL. THE (B)(4) LABEL HAD BEEN UTILIZED INSTEAD OF THE (B)(4) LABEL. A VALVE IS INCLUDED AS PART OF THE CONVENIENCE KIT AND WAS UTILIZED BY THE PERFUSIONIST PER THEIR NORMAL PROCESS. THERE WAS NO DELAY TO THE PROCEDURE OR PT HARM. COMPLAINT WILL BE INCLUDED IN ASSOCIATES AWARENESS TRAINING. ALL AVAILABLE INFO HAS BEEN PLACE ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND F/U. (B)(4).

    Description of Event or Problem · 1

    TERUMO WAS MADE AWARE BY OUR CUSTOMER OF THE FOLLOWING' "PLEASE BE ADVISED THAT THE TUBING PACKS FROM LOT RA27 THAT ARE LABELED AS HAVING POSITIVE PRESSURE RELIEF VALVE FACTORY INSTALLED ON THE VENOUS RESERVOIR DO NOT ACTUALLY HAVE THE VALVE. CONTINUE TO USE THE POSITIVE PRESSURE RELIEF VALVE INCLUDED IN THE ACCESSORY POUCH FOUND IN THE PACK. TERUMO HAS BEEN INFORMED OF THE ISSUE AND ARE INVESTIGATING THE LABELING ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214199 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 73431 RA27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK