BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11026480 · Received December 17, 2020

    Report

    Report Number
    2016493-2020-71306
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Report Date
    June 27, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    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. 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. THE CUSTOMER STATED THAT THERE IS 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 #: 00752167 CASE SUBJECT: NPI 8110 DID NOT COMMUNICATE WITH PCU ACCOUNT NAME: BANNER DESERT MEDICAL CENTER ACCOUNT #: 10011519 ASSET NAME: 8110 SYRINGE N. AMERICA V9.33.0 ASSET LOCATION: CONTACT: LIUS GONZALEZ CRUZ CONTACT EMAIL: CONTACT PHONE: 480-412-3708 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: LUIS HAD A SYRINGE 8110 SN (B)(4) DID NOT COMMUNICATE WITH PCU8015 FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8110 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: I TRANSFERRED TO LUIS TO COM FOR RGA NUMBER TO SEND UNIT IN FOR WARRANTY REPAIR. REF:_00D30Y0YR._5000L1K219X:REF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494143 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1