BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10934204 · Received December 2, 2020

    Report

    Report Number
    2016493-2020-54644
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Report Date
    December 3, 2018
    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 PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. 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

    (B)(4). (B)(4) NEED ASSISTANCE ON 8100 S/N (B)(4) IS SHOWING AN ERROR CODE 200.5040, THIS A SOFTWARE COMPATIBILITY ISSUE BETWEEN 8015 AND 8100. I TOLD (B)(4) THAT THE 8100 NEED TO RE-FLASHED TO V9.17.0.22 , THE EXISTING 8100 IS SHOWING AN OLDER VERSION 8.5.6.0 I ASK (B)(4) IF HE CAN LOCATE THE POINT OF CARE SOFTWARE (POC) V9.19 , HE TOLD ME THAT HE CAN¿T LOCATE THE CD COPY FOR THE POINT OF CARE AND ASKING ME IF I CAN REQUEST A COPY OF THIS CD TO (B)(4). I TOLD (B)(4)I WILL REQUEST A COPY OF THE CD ON HIS BEHALF. I WALK HIM THROUGH HOW TO CONFIGURE THE FLASH PACKAGE, SO WHEN HE RECEIVED THE POC SOFTWARE HE CAN BE ABLE TO CONFIGURE HIMSELF BUT I ALSO TOLD (B)(4) IF HE NEEDS HELP FEEL FREE TO GIVE ME A CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399848 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1