BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESITE® (LAD) SYSTEM

    MDR report key: 5567896 · Received April 11, 2016

    Report

    Report Number
    2523676-2016-00163
    Event Type
    Injury
    Date Received
    April 11, 2016
    Report Date
    April 27, 2015
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH SAMPLE ANALYSIS OR BATCH RECORD REVIEW COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, A REPRESENTATIVE FROM B. BRAUN MEDICAL INC. CONDUCTED A SIGHT VISIT AT THIS FACILITY IN ORDER TO PERFORM IN-SERVICE TRAINING AND TROUBLESHOOT THIS ISSUE. IT WAS REVIEWED WITH THE FACILITY TO TIGHTEN THE SET AN EXTRA 1/4 TURN WHEN ATTACHING TO THE CARESITE LUER ACCESS DEVICE IN ORDER TO ENSURE THE CARESITE OPENS. SINCE THE FACILITY HAS STARTED DOING THIS, THERE HAVE BEEN NO PUMP ALARMS OR OCCLUSIONS REPORTED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT # 1: REPORTS TWO 28 G PICC LINES WERE PLACED IN TWO DIFFERENT BABIES. AS SOON AS THEY WERE HOOKED UP TO IV FLUIDS WITH THE ADAPTORS, THE PUMPS ALARMED FOR OCCLUSION WITH HIGH PSI ON THE PUMP. IF A CLINICIAN WAS NOT THERE BOTH TIMES TO TROUBLESHOOT, THE LINES WOULD HAVE CLOTTED OFF. THESE LINES WERE LIFELINES FOR 24 WEEK BABIES. BOTH LINES WERE REMOVED BY OPENING UP THE CODE CART AND USING THE OLD PRODUCTS. WITHOUT A LUER LOCK DEVICE ON THE PICC LINES, CHANGING THE TUBING IS A PROBLEM WITH THE CENTRAL LINE BEING OPEN WITH TUBING CHANGES. THIS IS NOT BEST PRACTICE FOR A CENTRAL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224280 CARESITE® (LAD) SYSTEM CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Required Intervention