BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 12623451 · Received October 13, 2021

    Report

    Report Number
    1219343-2021-00130
    Event Type
    Injury
    Date Received
    October 13, 2021
    Report Date
    October 13, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK180185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A LITERATURE REVIEW, IT WAS NOTED ABOUT TEN HYPOTENSIVE ISSUES DURING A CLINICAL STUDY USING HAE EQUIPMENT. THESE EVENTS RESOLVED WITH NO INTERVENTION REQUIRED. WHILE NO DEVICE MALFUNCTION IS ALLEGED, A CAUSAL RELATIONSHIP BETWEEN THE PROCEDURES AND EVENTS COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    DURING A REVIEW OF A PUBLISHED LITERATURE ARTICLE, TEN EVENTS OF HYPOTENSION WERE NOTED. THERE WAS NO ALLEGED DEVICE MALFUNCTION. THERE WAS NO INDICATION THAT THE EVENTS REQUIRED ANY MEDICAL INTERVENTION. WHILE NO DEVICE MALFUNCTION IS ALLEGED, CASUAL RELATIONSHIP TO THE PROCEDURE COULD NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523328 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other