BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRY SYSTEM III

    MDR report key: 14918 · Received March 11, 1994

    Report

    Report Number
    14918
    Event Type
    Injury
    Date Received
    March 11, 1994
    Date of Event
    February 27, 1994
    Report Date
    March 10, 1994
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF SHORTNESS OF BREATH 1/2 HOUR PRIOR TO 4 HOUR DIALYSIS TREATMENT ENDING. PT SMOKER WITH COPD, NOT UNUSUAL COMPLAINT. WHEN PT DID POST DIALYSIS WEIGHT IT SHOWED HE HAD GAINED 4.1 KG INSTEAD OF LOOSING 2.1 KG. PT ADMITTED TO ER TRANSFERRED TO ICU FOR EMERGENCY POF TREATMENT. THE SUSPECT EQUIPMENT WAS TESTED ON 3/4/94 BY A COMBINATION OF HOSP PERSONNEL AND MFR MEDICAL TECHNICAL SPECIALISTS. IT WAS DETERMINED THAT VALVE VB2 ON THE BALANCE CHAMBERS FAILED ALLOWING FLUID TO BE TRANSFERRED TO PT WITH NO CORRESPONDING REVERSE TMP ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRY SYSTEM III DIALYSIS DELIVERY SYSTEM FII CGH MEDICAL, INC. CENTRY SYSTEM III

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R