BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 5042773 · Received August 31, 2015

    Report

    Report Number
    9616066-2015-01099
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 18, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K801614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: ICU MEDICAL CONNECTOR, LOT 3053029, THERAPY DATE (B)(6) 2015. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A DISCONNECTION AND LEAK WERE NOT CONFIRMED OR REPLICATED. VISUAL INSPECTION OF THE SET NOTED NO DEFORMITIES TO THE MALE LUER OR THE NON-BD MICROCLAVE. VISUAL INSPECTION UNDER A MICROSCOPE DID NOT REVEAL ANY CRACKS OR DAMAGES EITHER. FUNCTIONAL TESTING WAS PERFORMED AND NO LEAKS WERE DETECTED ANYWHERE BETWEEN THE NON-BD MICROCLAVE AND THE MALE LUER DURING GRAVITY INFUSION. PRESSURE TESTING WAS PERFORMED AND THERE WERE NO SIGNS OF LEAKING. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF A LEAK AND A DISCONNECTION WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EXTENSION SET BECAME DISCONNECTED FROM A NON-CAREFUSION NEEDLE-FREE CONNECTOR THREE TIMES DURING INFUSION OF TPN TO A PATIENT RESULTING IN LEAKAGE OF THE TPN. THE TUBING AND CONNECTOR WERE REPLACED. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED FROM MAUDE."CYCLIC TPN DISCOVERED DISCONNECTED (B)(6). MCI 00 CHANGED (B)(6). SMARTSITE EXTENSION SET20028E, LOT NUMBER 15046695 WAS FOUND DISCONNECTED FROM THE ICU MEDICAL MICROCLAVE MCI 00 NEUTRAL CONNECTOR, LOT NUMBER 3053029. SMALL AMOUNT OF TPN LEAKED OUT. THERE WAS A BRIEF INTERRUPTION OF TREATMENT. NO HARM TO PATIENT OR INTERVENTION REQUIRED. REPORTED TO CAREFUSION AND ICU MEDICAL. PRODUCTS SENT TO CAREFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575625 ALARIS EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 20028E 15046695

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR