BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11025171 · Received December 17, 2020

    Report

    Report Number
    2016493-2020-70027
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Report Date
    May 29, 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 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. THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. (B)(4). CASE DESCRIPTION: (B)(6) HAD A LVP8100 FAILED PATIENT SIDE OCCLUSION TEST. HE HAS REPLACED PATIENT SIDE PRESSURE SENSOR. BUT THE ISSUE WAS NOT RESOLVED. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8100. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: I REVIEWED TEST SET UP WITH (B)(6) AND FOUND OUT HIS TEST SET (8100-RCS) WAS OVER 3 MONTHS OLD. IT WAS USED WITH OVER 200 LVPS. I TOLD (B)(6) 8100-RCS IS GOOD FOR 60 USES ONLY. I ALSO RECOMMENDED (B)(6) TO USE A REGULAR INFUSION SET FOR PATIENT SIDE OCCLUSION TEST SO HE CAN SAVE 8100-RCS FOR RATE TEST. (B)(6) REPLACED A NEW INFUSION SET AND TEST THE PUMP AGAIN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493532 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1