BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11045798 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-73047
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    July 30, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. BASED ON THE FILE REVIEW, NO FURTHER ESCALATION IS REQUIRED PER 1501-006-000 SWI-SD-INF COMPLAINT ESCALATIONS, INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. 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 TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE.

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. CASE #: 00784546 CASE SUBJECT: NPI 8100 ERROR 210.6041 ACCOUNT NAME: ATLANTIC GENERAL HOSPITAL ACCOUNT #: 1010235 ASSET NAME: 8100 PUMP MODULE V9.1.17.7 ASSET LOCATION: CONTACT: (B)(6) CONTACT EMAIL: (B)(6) CONTACT PHONE: (B)(6) CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: CUSTOMER RECEIVES ERROR ON (B)(4). FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8100 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: CUSTOMER RECEIVES ERROR ON (B)(4) (S/N (B)(4). ASSISTED CUSTOMER TO IDENTIFY PROBLEMATIC FAULT FOR ERROR 210.6041. EXPLAINED TO CUSTOMER TO REPAIR/REPLACE THE DISPLAY BOARD IN THE FRONT DOOR OF THE 8100. CUSTOMER WILL CALL BACK, IF ANY FURTHER ASSISTANCE IS NEEDED. END CALL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516171 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1