BEUDAMED
    FDA Adverse Event Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 1941361 · Received December 21, 2010

    Report

    Report Number
    1124841-2010-00239
    Date Received
    December 21, 2010
    Report Date
    December 2, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, TERUMO IS STILL INVESTIGATING THIS ISSUE AND PLANS TO SUBMIT A FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED. (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 LEAKED. IT IS UNK WHETHER THE PRODUCT WAS CHANGED OUT. IT IS UNK WHETHER THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PT INVOLVEMENT. TWO ATTEMPTS WERE MADE TO OBTAIN THE UNK INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H MK03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK