BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE FX15RWC W/ 3L RES

    MDR report key: 6100524 · Received November 14, 2016

    Report

    Report Number
    1124841-2016-00399
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 13, 2016
    Report Date
    February 8, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K151389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON NOVEMBER 14, 2016. (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED, NO ANOMALIES WERE NOTED. THE SAMPLE WAS BUILT INTO A CIRCUIT WHERE BOVINE BLOOD WAS CIRCULATED AND THE PRESSURE DROP WAS DETERMINED AT EACH FLOW RATE. THE OBTAINED VALUES MET SPECIFICATIONS. THE BOVINE BLOOD WAS THEN CIRCULATED FOR 6 HOURS. NO OBSTRUCTION WAS OBSERVED THAT WOULD LEAD TO AN INCREASE IN THE PRESSURE. THE SAMPLE WAS RINSED AND VISUALLY INSPECTED. NO ANOMALIES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO MANUFACTURING ANOMALIES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE. EVALUATION IN PROGRESS. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR FAILED. THERE WAS A DELAY OF ONE (1) AND A HALF MINUTE. THERE WAS RESIDUAL BLOOD INSIDE THE OXYGENATOR ABOUT 100 CC BUT IT IS MIXED WITH PRIMING SOLUTION. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752189 STERILE FX15RWC W/ 3L RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX*FX15RW30C UG06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other