BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11044010 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-74592
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    August 15, 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 NOT RETURNED FOR SERVICING WHICH NOT 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

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. CASE #: (B)(4) CASE SUBJECT: NPI 8100 ERROR 13-1013-121 ACCOUNT NAME: (B)(6) MEMORIAL HOSPITAL ACCOUNT #: (B)(4) ASSET NAME: 8100 PUMP MODULE 9.17.0.22 ASSET LOCATION: CONTACT: (B)(6) CONTACT EMAIL: CONTACT PHONE: (B)(6) CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: SHEILA HAD ERROR 13-1013-121 ON LVP8100 SN (B)(4) FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8100 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: I RECOMMENDED SHEILA TO RE-FLASH SOFTWARE ON PUMP. IF RE-FLASHING SOFTWARE DID NOT RESOLVE THE ISSUE, SHEILA WILL REPLACE LOGIC BOARD. REF:_00D30Y0YR._5000L1KTEDN:REF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516937 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1