BEUDAMED
    FDA Adverse Event Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 1956426 · Received January 6, 2011

    Report

    Report Number
    1124841-2010-00265
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 15, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED ACTUAL DEVICE FOR EVAL; HOWEVER, TERUMO IS STILL INVESTIGATING THIS ISSUE AND WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE SHUNT SENSOR DISPLAYED A CALIBRATION ERROR MESSAGE "ARTERIAL K+". THE PRODUCT WAS CHANGED OUT. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI510H MG23

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK