BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE SET

    MDR report key: 5091043 · Received September 21, 2015

    Report

    Report Number
    9616066-2015-01168
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 9, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 LEAK WAS CONFIRMED. THE SET WAS VISUALLY INSPECTED FOR DAMAGES SUCH AS INCOMPLETE BONDING ENGAGEMENTS, CRACKS, KINKS, HOLES, AND TEARS IN THE TUBING AND ITS COMPONENTS. A VERTICAL HAIR LINE CRACK WAS FAINTLY VISIBLE ON THE FLL ADAPTOR (CAVITY 8) OF THE PRIMARY LINE. FURTHER VISUAL INSPECTION OF THE FLL ADAPTOR UNDER MAGNIFICATION REVEALED A VERTICAL HAIR LINE CRACK EXTENDING FROM ONE END OF THE ADAPTOR TO THE OTHER END, ON THE OPPOSITE SIDE OF THE GATE. SOME IRREGULAR STRESS MARKS WERE ALSO OBSERVED. THERE WERE NO OTHER DAMAGES OR ANOMALIES NOTED ON THE REMAINDER OF THE SET AND ITS COMPONENTS. FUNCTIONAL TESTING WAS PERFORMED; THE BLUE DYE WATER WAS OBSERVED FLOWING THROUGH THE TUBING. THE LIQUID WAS OBSERVED TO LEAK FROM THE FLL ADAPTOR OF THE PRIMARY LINE. FUNCTIONAL TESTING WAS CONTINUED AND BLUE DYE WATER WAS OBSERVED FLOWING THROUGH THE TUBING AND EXITING FROM THE MALE LUER. NO LEAKS WERE OBSERVED IN THE SECONDARY LINE OF THE SET. PRESSURE TESTING WAS PERFORMED AND LEAKING IN THE FORM OF AIR BUBBLES WAS OBSERVED EMANATING FROM THE FLL ADAPTOR OF THE PRIMARY TUBING. FURTHER VISUAL INSPECTION WAS PERFORMED BY SUPPLIER QUALITY ENGINEERING IN WHICH ENGINEERING CONFIRMED THIS IS AN ISSUE WITH THE MANUFACTURING PROCESS OF THE FEMALE LUER COMPONENT, WHICH IS MANUFACTURED BY A THIRD PARTY SUPPLIER. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT WAS IDENTIFIED AS A CRACK IN THE FLL ADAPTOR. THE CAUSE OF THE CRACK WAS NOT FULLY IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PCA FENTANYL AND NS WHERE INFUSING AND A LEAK WAS NOTED AT THE Y-SITE. NO PATIENT HARM CONFIRMED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621492 ALARIS PCA MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10800175 15056729

    Patients

    Seq Age Sex Outcome Treatment
    1