BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 3176959 · Received June 13, 2013

    Report

    Report Number
    1124841-2013-00111
    Event Type
    Death
    Date Received
    June 13, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT WAS NOT CONFIRMED. A RETENTION SAMPLE OF THE SAME LOT OF PRODUCT WAS TESTED FOR THE PRESENCE OF HEPARIN (CONGO RED TEST); AND THE UNIT WAS FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THE MOST PROBABLE CAUSE OF THE CLOTTING WAS THE USE OF THE SHUNT SENSOR FOR LONGER THAN THE TIME PRESCRIBED IN THE INFORMATION FOR USE (IFU) AND FOR A PROCEDURE FOR WHICH IT WAS NOT INTENDED. PER THE IFU: "THE DISPOSABLE SHUNT SENSORS ARE INTENDED FOR USE WITH CDI 500 MONITOR DURING CARDIOPULMONARY BYPASS PROCEDURE WHEN CONTINUOUS BLOOD GAS, PH, K+ AND TEMPERATURE MONITORING IS DESIRED." "THE SHUNT SENSORS ARE... SINGLE USE DEVICES, AND FOR USE IN CARDIOPULMONARY BYPASS PROCEDURES FOR UP TO 6 HOURS." "MAINTAIN ADEQUATE LEVELS OF ANTICOAGULATION DURING EXTRACORPOREAL CIRCULATION BY MONITORING ACTIVATED CLOTTING TIME (ACT) OR OTHER APPROPRIATE MEASUREMENT." (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), TWO SHUNT SENSORS (ARTERIAL AND VENOUS) CLOTTED. ACTS WERE MAINTAINED BETWEEN 160-200 WITH HEPARIN INFUSION. NEITHER SENSOR WAS CHANGED OUT; BOTH WERE CLAMPED OFF AND ISOLATED FROM THE CIRCUIT. THE PATIENT EXPIRED, BUT IT WAS NOTED BY THE CERTIFIED CLINICAL PERFUSIONIST (CCP) THAT THE SHUNT SENSOR CLOTTING WAS NOT RELATED TO THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268861 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H QA21D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death