BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 12623667 · Received October 13, 2021

    Report

    Report Number
    1219343-2021-00131
    Event Type
    Injury
    Date Received
    October 13, 2021
    Report Date
    October 13, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK950033
    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 50 HYPOTENSIVE ISSUES DURING A RETROSPECTIVE REVIEW OF ADVERSE EVENTS THAT USED 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. IT IS UNKNOWN IF THESE ADVERSE WERE PREVIOUSLY REPORTED, BUT IN HAE'S COMMITMENT TO PATIENT SAFETY, THESE EVENTS ARE BEING REPORTED OUT OF ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A REVIEW OF A PUBLISHED LITERATURE ARTICLE OF A REVIEW OF ADVERSE EVENTS, 50 EVENTS OF HYPOTENSION WERE NOTED. IT WAS DOCUMENTED THE EVENTS DID NOT REQUIRE ANY MEDICAL INTERVENTION. WHILE NO DEVICE MALFUNCTION IS ALLEGED, CASUAL RELATIONSHIP TO THE PROCEDURE COULD NOT BE RULED OUT. THESE EVENTS ARE A RETROSPECTIVE REVIEW AND IT IS UNKNOWN IF THESE WERE REPORTED PREVIOUSLY, BUT HAE IS COMMITTED TO PATIENT SAFETY AND IS REPORTING OUT OF ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524202 PCS2 PLASMA COLLECTION SYSTEM PCS2, LIST NO. 06002-CP-220 GKT HAEMONETICS CORPORATION 06002-CP-220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other