BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 10675182 · Received October 13, 2020

    Report

    Report Number
    2016493-2020-21518
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Report Date
    September 17, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K091308
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED: D.4 & H.4.

    Additional Manufacturer Narrative · 0

    CUSTOMERS RECEIVED NOTIFICATION OF THE FIELD ACTION. THE REPORTED ISSUE OF UNRESPONSIVE (SHORTED) KEYPAD IS CONFIRMED BASED ON THE FIELD ACTION. DEVICE REPAIR OR RETURNS ARE HANDLED WITHIN THE SCOPE OF THE FIELD ACTION. NO FURTHER COMPLAINT INVESTIGATION IS NECESSARY AS CAPA PR 1120033 WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50 FRONT CASES WITH KEYPAD ARE BEING REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FRONT CASE WITH KEYPAD WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 50 FRONT CASES WITH KEYPAD ARE BEING REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133628 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1