BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 4281379 · Received November 20, 2014

    Report

    Report Number
    1212122-2014-00006
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 28, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A CUSTOMER MADE CONNECTION THAT WAS NOT TIE BANDED AS PER THE INSTRUCTIONS FOR USE. CONFIRMED THAT THE LINE SENT BACK WAS LINE 16, EVIDENCE OF THE USER HAD PUSHED IT ONTO THE PORT. OTHER MARKS ON THE LINE APPEAR TO BE FROM A USER CLAMP. IN INCOMING INSPECTION RECORDS FOR THE NON-COATED TUBING WERE REVIEWED AND ALL MEASUREMENTS FOR DUROMETER, WALL THICKNESS, AND INNER DIAMETER WERE FOUND TO BE IN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    THE INCIDENT WAS REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP AS "BYPASS AS NORMAL, 3/4 OF THE WAY THROUGH, THE CARDIOLOGY LINE POPPED OFF THE CARDIOPLEGIA PORT ON THE OXYGENATOR." PER CLINICAL REVIEW THIS ISSUE OCCURRED APPROXIMATELY 95 MINUTES IN THE CARDIOPULMONARY BYPASS SURGERY. THE CUSTOMER CONNECTION WHICH HAD NOT BEEN TIE BANDED TO THE OXYGENATOR PORT, DISCONNECTED RESULTING IN 300-500 ML OF BLOOD LOSS. THE ARTERIAL PUMP WAS SLOWED FOR A FEW SECONDS (BUT NOT STOPPED) AND LINE WAS REATTACHED AND TIE BANDED. THE ARTERIAL FLOW WAS RETURNED TO PRE-DISCONNECT LEVELS AND THE PROCEDURE WAS NOT DELAYED. ACCORDING TO THE PERFUSIONIST, THERE WAS NO NEED TO TRANSFUSE THE PATIENT BECAUSE OF THE DISCONNECT. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753892 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORP. B72755 RL02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention