BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE

    MDR report key: 172567 · Received June 11, 1998

    Report

    Report Number
    MW1013964
    Event Type
    Other
    Date Received
    June 11, 1998
    Date of Event
    June 4, 1998
    Report Date
    June 9, 1998
    Manufacturer
    GAMBRO HEALTHCARE CORP.
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 6/4/98 AT 12:04 PT ON DIALYSIS FOR APPROX 1 HR WHEN GIVEN PROCARDIA 10MG FOR HIGH BLOOD PRESSURE. PT TAKEN OFF AND SENT TO ER FOR UNRELIEVED HIGH BLOOD PRESSURE. PT COMPLAINED OF ABDOMINAL PAIN, NAUSEA AND VOMITING. ALSO DIARRHEA AND UNCONTROLLED BLOOD PRESSURE. BLOOD WORK DRAWN. PT RETURNED TO ER ON 6/5/98 AT 11:23 AM WITH UNCONTROLLED HYPERTENSION, WEAKNESS, NAUSEA, VOMITING AND DIARRHEA. PT GIVEN PROCARDIA & BLOOD WORK DRAWN. PT TO ER 6/6/98 12:04 PM W/COMPLAINT OF WEAKNESS & PT TALKING OUT HER HEAD PER FAMILY. BLOOD DRAWN SENT TO DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE BLOOD TUBING FJK GAMBRO HEALTHCARE CORP. * 04D 15316

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other