BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORMAL SALINE PREFILLED FLUSH

    MDR report key: 309931 · Received December 22, 2000

    Report

    Report Number
    6000001-2000-00658
    Event Type
    Injury
    Date Received
    December 22, 2000
    Date of Event
    November 1, 2000
    Report Date
    November 29, 2000
    Manufacturer
    BAXTER HEALTHCARE COMPASS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS INCREASED INFECTION RATES OF CENTRAL LINES WHICH THEY ATTRIBUTE MAY BE FROM THE PREFILLED HEPARIN AND SALINE SYRINGES. CULTURES OF SOLUTIONS OF PREFILLED SYRINGES WERE NEGATIVE BUT CULTURES FROM THE OUTSIDE OF THE SYRINGES HAVE CULTURED CHYSEOMONAS LUTEOLA (35/40) AND ACINETOBACTER IWOFFII (5/40) IN THEIR LAB WHICH ARE THE SAME ORGANISMS CULTURED FROM THE CATHETERS OF APPROXIMATELY 50 PEDIATRIC HOME CARE AND INPATIENT ONCOLOGY PATIENTS. ACCOUNT DID NOT SUPPLY SPECIFIC INFORMATION, TYPE OF INFECTION OR TREATMENT ON EACH PATIENT. PRODUCTS IDENTIFIED: PRODUCT CODE/LOT NUMBER/MANUFACT. DATE 2K0905/KH00205/08/02/00, 2K0905/KH00107/02/22/00, 2K6050/B00062/05/23/00, 2K6030/B00100/07/19/00.

    Description of Event or Problem · 1

    ACCOUNT REPORTS INCREASED INFECTION RATES OF CENTRAL LINES WHICH THEY ATTRIBUTE MAY BE FROM THE PREFILLED HEPARIN AND SALINE SYRINGES. CULTURES OF SOLUTIONS OF PREFILLED SYRINGES WERE NEGATIVE BUT CULTURES FROM THE OUTSIDE OF THE SYRINGES HAVE CULTURED CHYSEOMONAS LUTEOLA (35/40) AND ACINETOBACTER IWOFFII (5/40) IN THEIR LAB WHICH ARE THE SAME ORGANISMS CULTURED FROM THE CATHETERS OF APPROXIMATELY 50 PEDIATRIC HOME CARE AND INPATIENT ONCOLOGY PATIENTS. ACCOUNT DID NOT SUPPLY SPECIFIC INFORMATION, TYPE OF INFECTION OR TREATMENT ON EACH PATIENT. PRODUCTS IDENTIFIED: PRODUCT CODE/LOT NUMBER/MANUFACT. DATE 2K0905/KH00205/08/02/00, 2K0905/KH00107/02/22/00, 2K6050/B00062/05/23/00, 2K6030/B00100/07/19/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORMAL SALINE PREFILLED FLUSH COMPASS PREFILLED SYRINGE FOZ BAXTER HEALTHCARE COMPASS NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention