BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3W

    MDR report key: 71780 · Received February 26, 1997

    Report

    Report Number
    71780
    Event Type
    Injury
    Date Received
    February 26, 1997
    Date of Event
    February 18, 1997
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN TO DIALYZE ON 2/18/97. 3 HRS INTO 4 HR TX PT C/O CRAMPING. PT REQUESTED TO COME OFF MACHINE DUE TO DISCOMFORT. AFTER RINSEBACK, PT BECAME NAUSEATED AND HAD EMESIS APPROX 500CC ORANGE IN COLOR AND TESTED HEME (+). BS -91.1. 25CC D-50 ORDERED BY MD. FOLLOW-UP BS 130. ALERT AND ORIENTED TO PERSON AND PLACE. INCOHERENT TO SOME QUESTIONS. PT SENT TO ER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRYSYSTEM 3W DIALYSIS MACHINE FII COBE RENAL CARE, INC. 333104001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization