BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11053484 · Received December 22, 2020

    Report

    Report Number
    2016493-2020-76255
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Report Date
    August 16, 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. 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 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 #: 00803939 CASE SUBJECT: NPI 8100 DID NOT COMMUNICATE WITH PCU ACCOUNT NAME: WEST PALM BEACH VA MEDICAL CENTER #548 ACCOUNT #: 1012361 ASSET NAME: 8100 PUMP MODULE V9.1.17.7 ASSET LOCATION: CONTACT: JOSE CARDOZA CONTACT EMAIL: [email protected] CONTACT PHONE: 561-422-6632 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: JOSE HAD A LVP8100 SN (B)(4) DID NOT COMMUNICATE WITH PCU FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8100 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: I RECOMMENDED JOSE TO SEND UNIT IN FOR FLAT FEE REPAIR. JOSE WILL GET A PO AND CONTACT COM DIRECTLY FOR RGA NUMBER AND SEND UNIT IN. REF:_00D30Y0YR._5000L1KTPYB:REF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522653 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1