BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL CARE

    MDR report key: 436606 · Received January 9, 2003

    Report

    Report Number
    436606
    Event Type
    Malfunction
    Date Received
    January 9, 2003
    Date of Event
    May 1, 2002
    Report Date
    May 30, 2002
    Manufacturer
    VITAL CARE REPS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TITLE: CONTAMINATED SLUSH DRAPE. A PT WAS UNDERGOING CORONARY ARTERY BYPASS GRAFTING X 6 AND INTRAOPERATIVE TRANSESOPHAGEL ECHOCARDIOGRAPHY. ICED SALINE SLUSH WAS USED TOPICALLY TO SUPPLEMENT THE MYOCARDIAL PROTECTION. THE WOUND WAS RINSED WITH SALINE CONTAINING ANTIBIOTICS, AND CLOSED IN ROUTINE FASHION. AFTER THE CASE WAS COMPLETED THE SLUSH MACHINE DRAPE WAS REMOVED. LACTATED RINGER'S SOLUTION WAS DISCOVERED IN THE SLUSH MACHINE BASIN. NO VISIBLE HOLE IN THE DRAPE WAS OBSERVED. ACCORDING TO OPERATING ROOM STAFF, THE SLUSH USED DURING THE CASE WAS CONTAMINATED. THERE ARE NO KNOWN EFFECTS TO THIS PT DUE TO THE USE OF LACTATED RINGER'S SOLUTION INSTEAD OF NORMAL SALINE AS THE SLUSH SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL CARE SLUSH DRAPE KKX VITAL CARE REPS, INC. VAE6652 D1138165

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other