BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 3893839 · Received June 12, 2014

    Report

    Report Number
    1124841-2014-00086
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVAL OF THE DEVICE THE COMPLAINT WAS CONFIRMED. THE UNIT WAS VISUALLY INSPECTED AND PRESSURIZED, AND A LEAK WAS OBSERVED AT THE THERMOWELL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THIS UNIT WAS SUFFICIENTLY CURED AND SEALED TO PASS THROUGH A 100 PERCENT LEAK TEST. THE ROOT CAUSE, A LEAK FROM THE THERMOWELL POSITION RESULTING FROM STRESS, WAS IDENTIFIED TO BE SHIPPING AND HANDLING PAIRED WITH THE COUPLING OF THE SENSOR TO THE BPM HEAD. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING CARDIOPULMONARY BYPASS THE SHUNT SENSOR LEAKED BLOOD. THE CUSTOMER NOTED THREE OCCURRENCES. ALTHOUGH THE PT'S AGE IS UNK, THE CASE IS ASSUMED TO BE PEDIATRIC DUE TO THE EVENT OCCURRING AT A PEDIATRIC HOSPITAL; 1 CC BLOOD LOSS. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348874 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H QN11A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other