BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR - 4000 GOLD

    MDR report key: 106718 · Received July 16, 1997

    Report

    Report Number
    6000002-1997-00611
    Event Type
    Malfunction
    Date Received
    July 16, 1997
    Report Date
    July 15, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CO'S INVESTIGATION REVEALED THAT IF TOO MUCH FREON WAS USED TO CLEAN THIS GROOVE AND IT WAS NOT ALLOWED TO PROPERLY EVAPORATE IT COULD WEAKEN THE BOND. SINCE THIS HOUSING IS MFG USING A CLEAN MOLDING PROCESS, CO FOUND THAT THE USE OF FREON TO CLEAN THE GROOVE WAS NOT NECESSARY. AS A RESULT, CO HAS ELIMINATED THE FREON CLEANING OPERATION. IN ADDITION, CO HAS IMPLEMENTED A SECOND APPLICATION OF ADHESIVE TO THIS CONNECTION IN ORDER TO FURTHER STRENGTHEN THE BOND BETWEEN THE HOUSING AND THE CONNECTOR. SINCE THE IMPLEMENTATION OF THESE CORRECTIVE ACTIONS, CO HAS NOT RECEIVED ANY SIMILAR REPORTS FOR UNITS PRODUCED AFTER THESE ACTIONS WERE IMPLEMENTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE OUTLET PORT CAME OUT DURING BYPASS. THE SURGEON MASSAGED THE HEART WHILE THE RESERVOIR WAS REPLACED. BYPASS CONTINUED WITHOUT FURTHER INCIDENT. 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 PP6F1847

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention