BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2504705 · Received March 23, 2012

    Report

    Report Number
    1212122-2012-00009
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    April 22, 2011
    Report Date
    February 27, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE; A COMPLAINT WAS NOT FILED AT THE TIME OF THE INCIDENT. FROM THE INFO GIVEN, NO CAUSE CAN BE DETERMINED AS TO WHETHER THIS EVENT WAS USER RELATED OR DUE TO A DEVICE MALFUNCTION. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED TO TERUMO CARDIOVASCULAR: "PER DOCUMENTS RECEIVED, IT IS REPORTED THAT AN AIR EMBOLUS ENTERED THE CPB CIRCUIT CAUSING SERIOUS INJURY AND ULTIMATELY PERMANENT DAMAGE TO THE PT ... DURING THE REPEAT CARDIOPULMONARY BYPASS THERE WAS NOTED TO BE A CIRCUIT MALFUNCTION. IT IS DOCUMENTED THAT AN AIR EMBOLUS WAS NOTED AND WAS PURGED. THIS COMPLAINT IS ASSOCIATED WITH (B)(4) WHICH IS FOR THE SYSTEM 1 UNIT USED DURING THIS CASE." TERUMO'S CLINICAL REVIEW FOR THIS REPORT STATES THAT, "THIS INCIDENT WAS NOT REPORTED BY MOBILE INFIRMARY TO TERUMO OR NOT VIA A FDA MEDWATCH REPORT. THE INCIDENT TOOK PLACE ON (B)(6) 2011 AND TERUMO BECAME INFORMED ON FEB 27, 2012 VIA SUMMONS RELATED TO COURT FILED LITIGATION DOCUMENT. DUE TO LITIGATION PROCEEDINGS, WE ARE NOT AT LIBERTY TO SPEAK TO THE CLINICIANS INVOLVED IN THIS INCIDENT. THE NEUROLOGY AND POST-OP NURSING NOTES DO CONTAIN MULTIPLE REFERENCES AIR EMBOLISM, SEIZURES, AND FAILURE TO RESPOND TO COMMANDS. THE CURRENT PT CONDITION IS NOT KNOWN. THE MEDICAL CHART DOES NOT INDICATE THE ACTUAL CIRCUIT MALFUNCTION OR INTERVENTION THAT WAS PERFORMED. IT IS CLEAR THE PT HAD SIGNS OF A NEUROLOGIC INSULT POST SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA NC07

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention| S CABG X 5| TERUMO SYSTEM 1 PERFUSION