BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1622890 · Received February 22, 2010

    Report

    Report Number
    1219702-2010-00002
    Event Type
    Other
    Date Received
    February 22, 2010
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    BSB
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS UNIT OR THE DISPOSABLE SET INVOLVED WAS NOT RETURNED FOR EVAL. THE BIOMEDICAL ENGINEER, AT THE HOSP WAS UNABLE TO FIND THE PROBLEM WITH THE UNIT, BUT HE BELIEVED THAT SOMEONE, IN THE OPERATING ROOM, MIGHT HAVE MIXED LACTATED RINGERS OR HEXTEND (CALCIUM CONTAINED SOLUTION) INTO THE LARGE RESERVOIR FORMING THE CLOT. THE STAFF REPLACED THE UNIT INCLUDING THE DISPOSABLE SET AND CONTINUED THE CASE WITHOUT INCIDENT. THERE ARE NO PROBLEMS WITH BOTH THE UNIT OR THE DISPOSABLE SET.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE BSB BELMONT INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1