BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 2008H

    MDR report key: 510951 · Received January 27, 2004

    Report

    Report Number
    MW1030982
    Event Type
    Injury
    Date Received
    January 27, 2004
    Date of Event
    December 22, 2003
    Manufacturer
    FRESENIUS USA
    Product Code
    FII
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT'S VENOUS ACCESS NEEDLE DISLODGED WITH RESULTING BLOOD LOSS. VENOUS PRESSURE FOUND TO BE 20-40 MMHG; DIALYSIS MACHINE VENOUS PRESSURE ALARM DID NOT SOUND. EXTENDED INVESTIGATION HAS SHOWN THE POSSIBILITY OF MACHINE MALFUNCTION WHEN EARLIER ALARM WAS SILENCED FOR PT ASSESSMENT. EVALUATION OF THE MACHINE'S PRIOR ALARM HAD SHOWN NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS 2008H DIALYSIS MACHINE USE IN OUTPATIENT-CENTER FII FRESENIUS USA 2008H *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L