BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6463921 · Received April 6, 2017

    Report

    Report Number
    9616066-2017-00584
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Report Date
    March 23, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 10013890; TEVADAPTOR BAG ACCESS; NON-CFN/BD EXTENSION SET; 100ML HOSPIRA BAG NDC 0409-7984-37 LOT 69-068-JT EXP 1 SEP 2018 NIVOLUMAB; 500ML B.BRAUN NDC 0264-7800-10 LOT J6S336 EXP 06/19 0.9% SODIUM CHLORIDE INJECTION; THERAPY DATE UNKNOWN. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    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 THAT ¿THE MALE LUER BROKE OFF INSIDE THE MATING NEEDLE FREE CONNECTOR¿ WAS CONFIRMED. VISUAL INSPECTION OBSERVED THAT THE MALE LUER TIP OF THE SUSPECT PRIMARY SET TO BE BROKEN OFF; WITH ONE SIDE SLIGHTLY HIGHER THAN THE OTHER. FURTHER VISUAL INSPECTION OF THE DAMAGED COMPONENT UNDER MAGNIFICATION OBSERVED A WHITISH COLORED STRESS MARKING ON THE BROKEN LUER TIP¿S LOWER SIDE. THE BROKEN OFF TIP OF THE MALE LUER WAS FOUND LODGED INTO THE RECEIVED NON-BD NEEDLELESS CONNECTOR. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE. THE ROOT CAUSE OF THE MALE LUER TIP BREAKING OFF WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MALE LUER BROKE OFF INSIDE OF THE MATING NEEDLE FREE CONNECTOR AFTER AN INFUSION OF NIVOLUMAB 210 MG/100 ML NORMAL SALINE AT 124 ML/HR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MALE LUER BROKE OFF INSIDE OF THE MATING NEEDLE FREE CONNECTOR AFTER AN INFUSION OF CHEMO. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245608 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION PRI TUBING

    Patients

    Seq Age Sex Outcome Treatment
    1 NEEDLE FREE CONNECTOR, MANF. UNK. TD UNK