BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEUMO CARDIOVASCULAR PROCEDURE KIT- CONVENIENCE TUBING PACK

    MDR report key: 5058012 · Received September 4, 2015

    Report

    Report Number
    1212122-2015-00010
    Event Type
    Injury
    Date Received
    September 4, 2015
    Date of Event
    August 14, 2015
    Report Date
    September 4, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS, CORP.
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. A 42 INCH LENGTH OF 1/4 X 1/16 -X-COATED TUBING WAS RETURNED AND A SPLIT OF APPROXIMATELY 0.55 INCH IN LENGTH WAS NOTED ON THE TOP OF THE TUBING. THIS X-COATED TUBING WAS MANUFACTURED FROM A LOT OF TUBING WHERE NO OTHER COMPLAINTS OF SPLITS HAVE OCCURED. SEVERAL TUBING DIMENSIONS WERE ASSESSED AROUND THE SPLIT OF THE TUBING AND ALL DIMENSIONS WERE WITH-IN SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE NOTED. ASSOCIATE AWARENESS TRAINING WILL BE CONDUCTED AS PART OF THE ON-GOING QUALITY PROGRAM. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING CARDIOPULMONARY BYPASS "THE PUMP BOOT RUPTURED". THIS DELAYED THE CASE BY LESS THAN 5 MINUTES AS THEY PROCEEDED TO CHANGE OUT THE PUMP BOOT WITH AND EXTRA ONE THAT WAS AVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PER CLINICAL REVIEW: THE PERFUSIONIST WAS ON CPB WITH A 7 KG PATIENT WHEN THE PUMP BOOT RACEWAY RUPTURED. THIS OCCURRED DURING CIRCULATORY ARREST, THEREFORE THEY WEREN'T ACTIVELY PUMPING. IT WAS AT THIS TIME THEY NOTED BLOOD DRIPPING IN THE RACEWAY. THE PERFUSIONIST PROCEEDED TO CHANGE OUT THE PUMP BOOT. THERE WAS NO DELAY TO THE PROCEDURE, NO PATIENT ISSUES, AND THE CASE FINISHED WITHOUT INCIDENCE. THEY DID EXPERIENCE AN APPROXIMATE 50 CC BLOOD LOSS, BUT THIS DIDN'T RESULT IN THE NEED TO TRANSFUSE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588644 TEUMO CARDIOVASCULAR PROCEDURE KIT- CONVENIENCE TUBING PACK CARDIOVASCULAR PROCEDURE KIT OEZ TERUMO CARDIOVASCULAR SYSTEMS, CORP. 75170 TF18

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R