BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10903836 · Received November 25, 2020

    Report

    Report Number
    2016493-2020-48948
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    September 13, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF SAFETY CLAMP ALARM FILE WAS OPENED TO DOCUMENT AN EVENT THAT THE CUSTOMER REPORTED. NO DEVICES OR LOGS WERE RETURNED FOR INVESTIGATION. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME. AN INVESTIGATION CAN¿T BE PERFORMED USING THE SITE VISIT ALONE. NO DEVICE HISTORY OR QN SEARCH WAS PERFORMED SINCE NO SERIAL NUMBER FOR THE SUSPECT DEVICE WAS REPORTED BY THE CUSTOMER. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SAFETY CLAMP ALARM DIDN'T SHOW UP IN THE KPI DASHBOARD, BUT NURSING HAS BEEN GETTING THEM. THE CUSTOMER STATES THEY ARE "POST UPGRADE". THERE IS NO REPORT OF PATIENT INVOLVEMENT. THE CUSTOMER WOULD LIKE TO KNOW IF THERE IS A WAY FOR THEM TO RUN A REPORT TO SEE HOW OFTEN THE ALARM IS OCCURRING. DURING A SITE VISIT, IT WAS NOTED THE FACILITY HAD A VARIETY OF THIRD PARTY PARTS.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF SAFETY CLAMP ALARM FILE WAS OPENED TO DOCUMENT AN EVENT THAT THE CUSTOMER REPORTED. NO DEVICES OR LOGS WERE RETURNED FOR INVESTIGATION. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME. AN INVESTIGATION CAN¿T BE PERFORMED USING THE SITE VISIT ALONE. NO DEVICE HISTORY OR QN SEARCH WAS PERFORMED SINCE NO SERIAL NUMBER FOR THE SUSPECT DEVICE WAS REPORTED BY THE CUSTOMER. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SAFETY CLAMP ALARM DIDN'T SHOW UP IN THE KPI DASHBOARD, BUT NURSING HAS BEEN GETTING THEM. THE CUSTOMER STATES THEY ARE "POST UPGRADE". THERE IS NO REPORT OF PATIENT INVOLVEMENT. THE CUSTOMER WOULD LIKE TO KNOW IF THERE IS A WAY FOR THEM TO RUN A REPORT TO SEE HOW OFTEN THE ALARM IS OCCURRING. DURING A SITE VISIT, IT WAS NOTED THE FACILITY HAD A VARIETY OF THIRD PARTY PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369627 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015.