BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE SET, EM2400

    MDR report key: 10379497 · Received August 7, 2020

    Report

    Report Number
    1416980-2020-04785
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    June 1, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    UDI-DI
    00085412477183
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D10, H3, H4 AND H6. H4: LOT MANUFACTURED BETWEEN JULY 02, 2019 TO JULY 04, 2019. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE CONNECTOR CAP ALONG WITH ALL THE VALVE BODY CAPS WERE REMOVED AND THE REPORTED CONDITION COULD NOT BE FOUND UPON MAGNIFIED INSPECTION. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL WAS FOUND AT THE SURFACE OF AN EXACTAMIX 2400 VALVE SET. THE FOREIGN MATERIAL WAS FURTHER DESCRIBED AS AN OILY SUBSTANCE. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843034 VALVE SET, EM2400 SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 60193698 00085412477183

    Patients

    Seq Age Sex Outcome Treatment
    1