BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000

    MDR report key: 187651 · Received September 15, 1998

    Report

    Report Number
    6000002-1998-00268
    Event Type
    Malfunction
    Date Received
    September 15, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING REWARMING THE VENOUS OUTPORT ADAPTER DROPPED FROM THE HSR-4000 RESERVOIR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HSR-4000 VENOUS RESERVOIR DTN BAXTER HEALTHCARE CORP. HSR-4000 PP6L2134

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other