BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO

    MDR report key: 565732 · Received March 11, 2004

    Report

    Report Number
    MW1034165
    Event Type
    Injury
    Date Received
    March 11, 2004
    Date of Event
    February 17, 2004
    Report Date
    March 11, 2004
    Manufacturer
    GAMBRO RENAL PRODUCTS
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS CONNECTED TO CRRT AND THE LINE BECAME DISCONNECTED AT THE SITE OF THE RETURN LINE WHERE THE STOPCOCK IS POSITIONED TO CONNECT THE IV LINE INFUSING THE CALCIUM GLUCONATE. PT LOST APPROXIMATELY 2 UNITS OF BLOOD WITHIN A 10 MINUTE PERIOD AND BECAME HYPOTENSIVE. NO ALARM IS ABLE TO DETECT THIS LOSS OF BLOOD. SUBSEQUENTLY HAD MI INFERIOR. ALSO DEVELOPED COMPLETE TRANSVERSE MYELOPATHY AT ROUGHLY THE T5 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO PRISMA SYSTEM PRE PUMP INFUSION SET FII GAMBRO RENAL PRODUCTS PRISMA *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R