BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS 2008 K

    MDR report key: 2479436 · Received December 8, 2008

    Report

    Report Number
    2479436
    Event Type
    Other
    Date Received
    December 8, 2008
    Date of Event
    November 21, 2008
    Report Date
    December 1, 2008
    Manufacturer
    FRESENIUS MEDICAL SERVICES NORTH AMERICA, FRESENIUS USA, INC.
    Product Code
    FII
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 1420 PM, CHARGE NURSE SUMMONED TO PATIENT'S MACHINE BY PCT, BLOOD NOTED ON THE FLOOR, ARTERIAL LINE HANGING DOWN WITH PUMP SEGMENT OUT FROM AROUND BLOOD PUMP, BLOOD LEAKING FROM ARTERIAL LINE JUST POST OF THE BLOOD PUMP SEGMENT ON LINE, PCT HAD TURNED PUMP OFF, THE ARTERIAL LINE GUIDE WAS BROKE OFF. ARTERIAL BLOOD RETURNED, UNABLE TO RETURN VENOUS. H AND H DRAWN, EXTRA 250CC SALINE GIVEN. PATIENT WITHOUT COMPLIANT OF CHEST PAIN. NO SHORTNESS OF BREATH BP 103/59, TX DC'D, DOCTOR (B)(6) NOTIFIED. HCT 34.23 HGB = 11.2. HAD PATIENT REMAINED IN THE UNIT FOR OBSERVATION 30-45 MINUTES. PATIENT REASSESSED SITTING B/P 104/54 STANDING BP 114/62. PATIENT DISCHARGED FROM UNIT AMBULATORY WITH NO COMPLAINTS. PATIENT WAS INSTRUCTED SHOULD ANY SYMPTOMS OF CHEST PAIN SHORTNESS OF BREATH TO GO TO THE EMERGENCY ROOM, PATIENT VOICED UNDERSTANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS 2008 K HEMODIALYSIS MACHINE FII FRESENIUS MEDICAL SERVICES NORTH AMERICA, FRESENIUS USA, INC. 2008K NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other