BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXTER MEDI-VAC GUARDIAN SUCTION SYSTEM

    MDR report key: 43205 · Received October 21, 1996

    Report

    Report Number
    43205
    Event Type
    Death
    Date Received
    October 21, 1996
    Date of Event
    October 7, 1996
    Report Date
    October 15, 1996
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    JCX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH AN NG TUBE WAS FOUND APPROX. 7 HRA POST OP HAVING HAD A LARGE EMESIS AROUND AN NG TUBE. PT HAVING DIFFICULTY BREATHING OBVIOUSLY HAVING ASPIRATED WHILE VOMITING. PT INTUBATED AND PLACED ON A VENTILATOR. PT DID NOT RESPOND TO THERAPY, LIFE SUPPORT WAS DISCONTINUED AFTER 48 HRS AND PT EXPIRED. UPON INVESTIGATION, IT WAS NOTED THAT THE FILTER FLOAT AT THE TOP OF THE SUCTION CANISTER WAS "STUCK" AND THEREFORE THERE WAS NO SUCTION TO THE PT WHICH APPARENTLY RESULTED IN THE PT'S VOMITING. (CANISTER HAD BEEN EMPTIED WHEN PT WENT TO SURGERY AND WAS RECONNECTED APPROX. 6 HRS LATER). SMEAR - MODERATE WBC, FEW EPITHELIAL CELLS MANY GRAM NEGATIVE BACILLI, FEW GRAM POSITIVE COCCI AND BACILLI. CULTURE - 4+ GROWTH PROBABLE PSEUDOMONAS 2+ GROWTH SECOND GRAM NEGATVIE BACILLUS IDENTIFICATION AND SENSITIVITIES TO FOLLOW. 12:30 AM THIS PORTABLE CHEST SHOWS 1. MILD PNEUMONIA IN BILATERAL LUNG BASES AS DESCRIBED. 2. ENDOTRACHEAL TUBE IN SATISFACTORY POSITION. 3. NO SIGNIFICANT CHANGE IN LEFT SUBCLAVIAN CATHETER. 6:30 AM MILD WORSENING OF PNEUMONIAS OF BILATERAL LOWER LUNG FIELDS. 10:50 AM PORTABLE CHEST SHOWS ASPIRATION PNEUMONIA IN BILATERAL LOWER LUNG FIELDS AS BEFORE. ENDOTRACHEAL TUBE IN SATISFACTORY POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER MEDI-VAC GUARDIAN SUCTION SYSTEM SUCTION CANISTER JCX PHARMASEAL DIV. BAXTER HEALTHCARE CORP. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| L| R CENTRAL LINE STARTED ON 10/7/96