BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 9720431 · Received February 18, 2020

    Report

    Report Number
    9616066-2020-00536
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Report Date
    February 3, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SITE VISIT THAT A TUBING SEPARATION OCCURRED WHILE A VASOPRESSOR WAS INFUSING. THE CLINICIAN CANNOT RECALL IF IT WAS LEVOPHED OR ANOTHER MEDICATION. AND THE EVENT DATE WAS UNKNOWN. THE TUBING SEPARATED AT THE JUNCTURE OF THE UPPER FITMENT AND PUMP TUBING SEGMENT WHILE IN THE CHANNEL. THE TUBING SEPARATED WHILE MOVING A PATIENT. THE CLINICIAN BELIEVED THE TUBING SEPARATION WAS THERE FAULT, AND DID NOT REPORT THE EVENT. NO PATIENT HARM OCCURRED AND THIS EVENT TOOK PLACE ON THE CARDIO-THORACIC INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183550 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1