BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10988715 · Received December 10, 2020

    Report

    Report Number
    2016493-2020-61412
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Report Date
    March 13, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS NOT PERFORMED BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FOR THE SUSPECT DEVICE. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THE FOLLOWING CASE HAS BEEN OPENED IN SALESFORCE AND MARKED AS A COMPLAINT OR PRODUCT DISCREPANCY. PLEASE REVIEW THE FOLLOWING DETAILS AND CLICK THE LINK BELOW TO REVIEW THE CASE ITSELF. (B)(4). ASSET: 8100 PUMP MODULE 9.17.0.22. CASE DESCRIPTION: (B)(6) HAD A UNIT WITH 242-4030 ERROR 8100 9891119. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT. FAILURE PROBLEM TYPE: 8100. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: (B)(6) CHANGED EVERYTHING IN THE UNIT EXCEPT THE BEZEL ASSEMBLY. TOLD HIM MORE OFTEN THAN NOT THAT IS THE CAUSE. HE IS GOING TO REPLACE IT AND IF NOTHING CHANGES HE WILL SEND THE UNIT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446746 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1