BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR - 4000 GOLD

    MDR report key: 114294 · Received August 13, 1997

    Report

    Report Number
    6000002-1997-00670
    Event Type
    Malfunction
    Date Received
    August 13, 1997
    Date of Event
    July 11, 1997
    Report Date
    August 13, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE VENOUS OUTLET PORT ON THE VENOUS RESERVOIR CAME OFF WHILE THE PT WAS ON CPB. NO PT INJURY WAS REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HSR - 4000 GOLD VENOUS RESERVOIR DTN BAXTER HEALTHCARE CORP. HSR-4000 GOLD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other