BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSYTEM III INFUSION PUMP

    MDR report key: 11299841 · Received February 9, 2021

    Report

    Report Number
    2016493-2021-24873
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Report Date
    January 29, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403928659
    PMA / PMN Number
    K933545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT AUTHORIZE OR RESPOND TO ANY DEVICE REPAIR REQUEST. 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

    CHANNEL A CANNOT BE USE THERE WAS NO PATIENT INVOLVEMENT 01/29/2018 06:38:03 ZENITH SOMANI (ZSOMANI) PHONE 800-387-8309 1 02/02/2018 06:02:38 JAYMIN VAIDYA (JVAIDYA) 1ZR236E61444705583

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197596 MEDSYTEM III INFUSION PUMP PUMP, INFUSION FRN CAREFUSION SD 2865 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1