BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000 GOLD

    MDR report key: 109881 · Received July 28, 1997

    Report

    Report Number
    6000002-1997-00634
    Event Type
    Malfunction
    Date Received
    July 28, 1997
    Report Date
    July 25, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    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 HAS 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 REC'D ANY SIMILAR REPORTS FOR UNITS PRODUCED AFTER THESE ACTIONS WERE IMPLEMENTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT FIVE MINUTES INTO BYPASS THE OUTLET CONNECTOR OF THE RESERVOIR BECAME DETACHED AND 350 ML OF BLOOD WAS LOST. THE RESERVOIR WAS REPLACED. 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 GOLD VENOUS RESERVOIR DTN BAXTER HEALTHCARE CORP. HSR-4000 GOLD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other