BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3W

    MDR report key: 71773 · Received February 27, 1997

    Report

    Report Number
    71773
    Event Type
    Injury
    Date Received
    February 27, 1997
    Date of Event
    February 18, 1997
    Report Date
    February 27, 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 FOR TREATMENT ON 2/18/97. PT C/O CRAMPING THROUGHOUT TX. PT HAD 4.2 KILOS TO PULL. TARGET WT DECREASED TO TRY AND RESOLVE CRAMPING. AFTER PT TAKEN OFF MACHINE AT END OF TX, PT C/O NOT FEELING WELL. TREMBLING OF ARMS NOTED. HEAD BOBBING. PT BECAME INCOHERENT. VITAL SIGNS WNL. PT PLACED ON O2 2L. MD NOTIFIED. 911 CALLED. NEUROLOGICAL CHECK INDICATED LT HAND GRASP (+) 1; RT HAND GRASP (+) 4. CONCERN OVER POSSIBLE CVA. PT HAS HISTORY. SENT TO ER.

    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 83 YR Hospitalization