BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6100118 · Received November 14, 2016

    Report

    Report Number
    9616066-2016-01545
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 26, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF LEAKING AT THE CONNECTION OF A TEXIUM-BONDED SECONDARY SET TO A PRIMARY SET WAS NOT CONFIRMED OR REPLICATED. THE TUBING CONFIGURATION, WITH THE SECONDARY SET Y-ED INTO THE PRIMARY SET, FUNCTIONED EFFECTIVELY THROUGHOUT TESTING. NO LEAKS WERE OBSERVED AT ANY TIME. VISUAL INSPECTION UNDER MAGNIFICATION OBSERVED DAMAGE TO THE THREADS OF THE SMARTSITE THAT WERE CONSISTENT WITH THE EFFECTS OF OVER-TORQUE DURING ATTACHMENT. THE ROOT CAUSE OF THE LEAKING COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: NON-CFN PRIMARY SET ; 500ML B.BRAUN, NDC 0264-7800-10, LOT J6H128, EXP 12/18, CYCLOPHOSPHAMIDE IN 0.9% NACL 588ML INFUSION; 500ML B. BRAUN BAG NDC 0264-7800-10, LOT J6K040, EXP 02/19, 0.9% SODIUM CHLORIDE INJECTION; 250ML B.BRAUN BAG, NDC 0264-7800-20, LOT J6K079, EXP 08/18, 0.9% SODIUM CHLORIDE INJECTION; THERAPY DATE: (B)(6) 2016. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF CYCLOPHOSPHAMIDE WHERE THE SECONDARY TEXIUM END IS ATTACHED TO THE PRIMARY TUBING DURING AN INFUSION. THE NURSE DETACHED THE SECONDARY TUBING AND THEN REATTACHED IT. NO FURTHER LEAKING WAS OBSERVED AND THE INFUSION COMPLETED. THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751335 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2429-0500 16096343

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR (B)(4)