BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAWASUMI

    MDR report key: 17461 · Received August 11, 1994

    Report

    Report Number
    17461
    Event Type
    Other
    Date Received
    August 11, 1994
    Date of Event
    December 15, 1993
    Report Date
    January 25, 1994
    Manufacturer
    KAWASUMI
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    10 MINUTES AFTER INITIATION OF DIALYSIS, PATIENT COMPLAINED OF FEELING HOT AND TINGLING IN RIGHT ARM. PATIENT HAS LEFT UPPER ARM GRAFT. PATIENT DENIED CHEST PAIN OR SHORTNESS OF BREATH. BP 140/80, PULSE 80 AND REGULAR. PATIENT STATED, "I'M PROBABY JUST HAVING A PANIC ATTACK, I'LL BE ALRIGHT." SYMPTOMS RESOLVED WITHIN ONE MINUTE WITHOUT INTERVENTION. 1 HOUR 10 MINUTES LATER, VENOUS BLOODLINE CLOTTED. VENOUS BLOODLINE PRIMED AND DIALYSIS RESUMED. WITHIN 5 MINUTES, PATIENT COMPLAINED OF SHORTNESS OF BREATH, BP DROPPED TO 50/PALP, PATIENT COMPLAINED OF NAUSEA AND FACIAL FLUSHING. 400 CC NSS GIVEN AND OXYGEN THERAPY INITIATED. BLOOD RETURNED AND TREATMENT DISCONTINUED. T 97.6. SYMPTOMS RELIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAWASUMI VENOUS BLOODLINE USED FOR DIALYSIS DXG KAWASUMI KLA A002/V001 2913K6

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other ARTERIAL BLOODLINE: NMC 03-7203-7| MACHINE: FRESENIUS 2008| DIALYZER: FRESENIUS F80, 8TH USE.