BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR - 4000

    MDR report key: 109876 · Received July 28, 1997

    Report

    Report Number
    6000002-1997-00633
    Event Type
    Malfunction
    Date Received
    July 28, 1997
    Report Date
    July 25, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING BYPASS, BLOOD LEAKED FROM THE OUTLET PORT OF THE VENOUS RESERVOIR. THE RESERVOIR WAS EXCHANGED. NO PT ISSUES WERE REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HSR - 4000 VENOUS RESERVOIR DTN BAXTER HEALTHCARE CORP. HSR-4000 PP6H2156

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention