BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11138318 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-04711
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    March 24, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    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. TECHNICAL SUPPORT TROUBLESHOOT WITH THE CUSTOMER OVER THE PHONE AND CONFIRMED CUSTOMER REPORTED ISSUE OF ERROR CODE 354.6770 ON 8110 UNIT. TECHNICAL SUPPORT - TECH HAS ERROR CODE 354.6770 ON SYRINGE UNITS HAS TO DO WITH THE PRESSURE SENOR ON UNIT WILL NEED TO BE REPLACE, CONFIRM PART FOR SENOR BOARD TRANSFER TECH TO ORDER MGR TO PLACE ORDER FOR BOARD.. ADDITIONAL COMMENTS: TECH SUPPORT - ERROR CODE 354.6770 ON SYRINGE UNITS HAS TO DO WITH THE PRESSURE SENOR ON UNIT WILL NEED TO BE REPLACE ADDITIONAL COMMENTS 2: 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 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. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    CASE #: 01032492 CASE SUBJECT: NPI ERROR CODE 354.6770 ON 8110 UNIT ACCOUNT NAME: CHILDRENS HOSPITAL KINGS DAUGHTERS ACCOUNT #: 1103400 ASSET NAME: 8015BD PCU DOM V9.33.1.2 A/B/G/N ASSET LOCATION: CONTACT: DREE SAMMON CONTACT EMAIL: CONTACT PHONE: CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: TECH CALLED IN WITH HELP ON ERROR CODE 354.6770 ON 8110 UNIT SERIAL # (B)(4). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: TECH HAS ERROR CODE 354.6770 ON SYRINGE UNITS HAS TO DO WITH THE PRESSURE SENOR ON UNIT WILL NEED TO BE REPLACE, CONFIRM PART FOR SENOR BOARD TRANSFER TECH TO ORDER MGR TO PLACE ORDER FOR BOARD. TECH THANK ME FOR MY ASSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39173 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1