BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 117150 · Received August 27, 1997

    Report

    Report Number
    2937457-1997-00056
    Event Type
    Other
    Date Received
    August 27, 1997
    Date of Event
    July 19, 1997
    Report Date
    July 29, 1997
    Manufacturer
    FRESENIUS MEDICAL CARE- NORTH AMERICA
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS PT WAS SCHEDULED TO DIALYZE FOR 2 HRS. APPROXIMATELY 15 MINUTES INTO THE TREATMENT, THE PT C/O CHEST PAIN AND BECAME HYPOTENSIVE. SHE WAS GIVEN 500 ML OF SALINE AND OXYGEN WAS ADMINISTERED. TREATMENT WAS RESUMED AFTER SHE WAS STABILIZED BUT SHE HAD ANOTHER EPISODE OF HYPOTENSION AND DIMINISHED RESPONSIVENESS. BP WAS 64/54. SHE WAS GIVEN ANOTHER 800ML OF SALINE AND DIALYSIS WAS DISCONTINUED. SHE WAS STILL HYPOTENSIVE POST TREATMENT SO SHE WAS GIVEN ADDITIONAL SALINE. THE PT WAS DISCHARGED HOME WHEN STABLE. THERE WAS NO SERIOUS PT INJURY. BASED ON THE REPORTED PRE AND POST WTS., WHAT THE MACHINE INDICATED WAS REMOVED AND TOTAL SALINE GIVEN (2 LITERS), THERE WAS REPORTEDLY AN EXCESSIVE FLUID REMOVAL OF 3.2 KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FII FRESENIUS MEDICAL CARE- NORTH AMERICA 2008E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR