BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPS 550

    MDR report key: 141961 · Received January 6, 1998

    Report

    Report Number
    1423500-1998-00006
    Event Type
    Injury
    Date Received
    January 6, 1998
    Date of Event
    December 8, 1997
    Report Date
    December 8, 1997
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED CRAMPS AND FEELING FAINT AROUND 3 1/2 HRS INTO HEMODIALYSIS TREATMENT ON DEVICE. 200CC NS ADMINISTERED. B/P DOWN TO 69/36 AND AN ADDITIONAL 200CC NS ADMINISTERED. PT BECAME DIAPHORETIC AND SYSTOLIC B/P DOWN TO 60MMHG. 200CC OF NS ADMINISTERED, 02 APPLIED, AND TREATMENT PARAMETERS DECREASED. B/P UP TO 98/46 AND 200CC NS ADMINISTERED. PT REPORTED MODERATE CRAMPING AND B/P UP TO 114/60 AFTER A TOTAL OF 800CC NS. 12.5 GRAMS OF MANNITOL WERE ADMINISTERED AND B/P INCREASED TO 168/80 DIALYSIS TREATMENT DISCONTINUED AFTER APPROXIMATELY 4 HRS. PT REC'D A TOTAL OF 1000CC NS INCLUDING RINSE TO GIVE BLOOD BACK. HEALTHCARE PROFESSIONAL REPORTED ULTRAFILTRATE CONTROLLER "WAS READING THE RIGHT AMOUNT WHEN IT ACTUALLY TOOK MORE OFF." 12/23/97 PER DIRECTOR OF UNIT, PT HAS REC'D SUBSEQUENT TREATMENT WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPS 550 SPS 550 FKP BAXTER HEALTHCARE CORPORATION 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention