BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10799882 · Received November 6, 2020

    Report

    Report Number
    2016493-2020-31892
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Report Date
    April 5, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Removal / Correction Number
    TBD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER-STATED PROBLEM WAS CONFIRMED DURING THE SERVICE REPAIR PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED 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. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. .

    Description of Event or Problem · 1

    (B)(4). ISSUE: KEYPAD. ANALYSIS: SEVERAL CRACKS ON FLEX CABLE NOTED. MAIN ISSUE GND 5TH TRACE OPEN. OPEN GND CAUSES ALL KEYS TO BE NON-FUNCTIONAL. LOCATION OF OPEN ON FLEX: AT CONNECTOR BEND (NOTED SEVERAL NICKS/CRACKS). PART WILL BE PROCESSED TO QE. REWORK: YES. REPLACE TC10008458 DOOR/KEYPAD. DISPOSITION: LVP TO BE ROUTED TO SERVICE FOR NORMAL PROCESS. (B)(4.) REPLACED KEYPAD & FRONT DOOR. MISSED TAT INVESTIGATED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269260 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1