BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: THERMISTOR 5.80CM

    MDR report key: 2421973 · Received December 20, 2011

    Report

    Report Number
    2242445-2011-00201
    Event Type
    Malfunction
    Date Received
    December 20, 2011
    Date of Event
    November 22, 2011
    Report Date
    December 19, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYG
    PMA / PMN Number
    K833572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS PLACED AND THEY WERE UNABLE TO OBTAIN CARDIAC OUTPUT. AS A RESULT, BOTH CATHETER AND THERMODILUTION BAG WERE REMOVED AND REPLACED. REFERENCE MDR# 2242445-2011-00202 FOR THE SECOND EVENT INVOLVING THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: THERMISTOR 5.80CM BALLOON THERMODILUTION CATHETER PRODUCTS DYG ARROW INTL., INC. MF1094502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN