BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11299865 · Received February 9, 2021

    Report

    Report Number
    2016493-2021-24994
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Report Date
    January 4, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    ISSUE ON THE MECH ASSEMBLY. BROKEN POST. THERE WAS NO PATIENT INVOLVEMENT. 01/04/2018 06:13:31 ZENITH SOMANI (ZSOMANI) PHONE 800-387-8309 1 01/09/2018 09:36:25 JUSTIN SEYBERT (JSEYBERT) 1ZR236E62045466702 02/14/2018 12:36:41 JOSEPH KUHLS (JKUHLS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197914 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1