BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRAT

    MDR report key: 315704 · Received February 8, 2001

    Report

    Report Number
    MW1021040
    Event Type
    Death
    Date Received
    February 8, 2001
    Date of Event
    January 29, 2001
    Report Date
    February 8, 2001
    Manufacturer
    COBE CARDIOVASCULAR INC. DIV SORIN BIOMEDICAL INC
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT HAD UNDERGONE A TOTAL KNEE REPLACEMENT PROCEDURE IN THE SURGERY DEPT. DURING THE SURGICAL PROCEDURE, BLOOD RECOVERY TUBING FOR THE CELL-SAVER WAS PLACED AT THE SURGICAL SITE. FOLLOWING A STAY IN THE PACU (RECOVERY), THE PT WAS TRANSFERRED TO AN ORTHOPEDIC WING OF THE HOSP. WHILE BEING SITUATED IN A ROOM ON THE ORTHOPEDIC WING, THE SUCTION TUBING FOR THE CELL-SAVER WAS CONNECTED TO THE WALL-MOUNTED OXYGEN OUTLET. PT ARRESTED SHORTLY THEREAFTER AND WAS UNABLE TO BE REVIVED. AFTER DISCUSSION WITH ALL PARTIES INVOLVED AND WITH THE ADMINISTRATIVE PERSONNEL OF THIS INSTITUTION, AND FOLLOWING REVIEW BY BIOMEDICAL STAFF, IT IS DETERMINED THAT THE CELL-SAVER WAS NOT THE CAUSE OF THE DEATH OF THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4621 BRAT BLOOD COLLECTION RESERVOIR CAC COBE CARDIOVASCULAR INC. DIV SORIN BIOMEDICAL INC 30 UM FILTER *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death