BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEURMO M121

    MDR report key: 24242 · Received February 4, 1994

    Report

    Report Number
    24242
    Event Type
    Injury
    Date Received
    February 4, 1994
    Date of Event
    October 12, 1993
    Report Date
    November 17, 1993
    Manufacturer
    MPD TO FILL OUT.
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DENIED COMPLAINTS PRETREATMENT. UPON INITIATION TO TREATMENT PATIENT COMPLAINED OF SHORTNESS OF BREATH, DIZZINES, FEET ITCHING, HANDS SWELLING, BLOOD PRESSURE DESCREASED TO 70/P. PATIENT WAS RINSED BACK. NORMAL SALINE & ALBUMIN GIVEN. BP HAD INCREASED TO 100/P. 9/14 WAS CALLED. PT PLACED ON 02 AND TRANSPORTED TO THE E.R.*MACHINE TESTED NEGATIVE FOR BLEACH 10/12.*DIALYZER TESTED NEGATIVE FOR FORMALDEHYDE 10/12.*ALL TESTS ON MACHINE PASSED. 10/12.*ALL PROCEDURES FOLLOWED 10/12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEURMO M121 HEMODIALYZER KOC MPD TO FILL OUT. 8893B26

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization NMC ARTERIAL LINE 037228-4 R3D019 LOT #| NMC VENOUS LINE 037314-2 R32087 LOT #