BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SURGERY KIT FOR AUTOTRANSFUSION

    MDR report key: 19041 · Received January 19, 1995

    Report

    Report Number
    MW1004793
    Event Type
    Malfunction
    Date Received
    January 19, 1995
    Date of Event
    January 4, 1995
    Report Date
    January 6, 1995
    Manufacturer
    MEDTRONIC ELECTROMEDICS, INC.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON NUMEROUS OCCASIONS WITH THE LAST INCIDENT OCCURRING 1/4/95, THE BOWL PORTION OF THE DISPOSABLE SURGERY KIT FOR AUTOTRANSFUSION HAS CRACKED, CAUSING INTERRUPTION OF THE AUTOTRANSFUSION PROCEDURE. REPS FOR THE COMPANY HAVE BEEN NOTIFIED EACH TIME AND REPORTED TO RPTR'S HOSP TO PERFORM THE NECESSARY CLEANING AND PREVENTIVE MAINTENANCE OF THE INSTRUMENT AFTER THE BOWL BREAKAGE, RESULTING IN FLUID CONTAMINATION. PERFUSIONISTS AT RPTR'S INSTITUTION REPORT THAT THIS PROBLEM STARTED WHEN DESIGN CHANGES WERE MADE TO THE DISPOSABLE KITS. A MFR REP RESPONDED ON 1/15/95 TO INSPECT THE CELL SAVER INSTRUMENT AND THE DEFECTIVE DISPOSABLE KIT. BIOMEDICAL INSPECTED THE CRACKED BOWL USED ON 1/4/95. THE CRACK APPEARS TO HAVE STARTED AT THE BASE OF THE BOWL IN THE AREA OF SOME TYPE OF REINFORCEMENT WELD OF THE PLASTIC COMPONENTS. THE INSIDE OF THE CELL SAVER CENTRIFUGE WAS CONTAMINATED WITH A LARGE QUANTITY OF BLOOD WHICH LEAKED THROUGH THE CRACK IN THE BOWL DURING THE PROCEDURE. MFR TO PM AND CLEAN THE CELL SAVER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SURGERY KIT FOR AUTOTRANSFUSION DISPOSABLE SURGERY KIT FOR AUTOTRANSFUSION CAC MEDTRONIC ELECTROMEDICS, INC. BT-722H

    Patients

    Seq Age Sex Outcome Treatment
    1 *