BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL BLOOD LINE

    MDR report key: 24817 · Received July 25, 1995

    Report

    Report Number
    24817
    Event Type
    Injury
    Date Received
    July 25, 1995
    Date of Event
    May 22, 1995
    Report Date
    May 26, 1995
    Manufacturer
    NATIONAL MEDICAL CARE
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPROX 3 HOUS INTO THE TREATMENT THE PT COMPLAINED OF SHORTNESS OF BREATH AND CHEST PAIN. NTG WAS WAS GIVEN ALONG WITH O2 AT 4L WITH NO RELIEF. THE DR ORDERED THE TREATMENT TO BE DISCONTINUED. DURING TAKE OFF THE PT CARE TECH HEARD A "SUCKING NOISE" AND NOTED A LARGE KINK IN THE ARTERIAL LINE AT THE CONNNECTION OF THE LINE TO THE DIALYZER. NO MORE BLOOD WAS GIVEN TO THE PT. LAB WORK WAS DRAWN. THE PT STATES THE CHEST PAIN HAD "EASED UP" AND SHE APPEARED LESS ANXIOUS. PULSE 57 AND REG REPS 12. HER BP WAS 183/100 WHEN SITIING AND 115/53 WHEN STANDING. SHE STATED THE CHEST PAIN WAS COMING BACK. O2 WAS PUT BACK ON AT 2L. FIVE MINUTES LATER SHE FELT BETTER. HER BP WAS 111/65. O2 WAS DISCONTINUED. SHE WAS THEN DISCHARGED TO HOME PER MD ORDER STATING SHE FELT BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL BLOOD LINE ARTERIAL BLOOD LINE FJK NATIONAL MEDICAL CARE 9608 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R HEMODIALYZER