BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10974929 · Received December 9, 2020

    Report

    Report Number
    2016493-2020-62022
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Report Date
    March 25, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S CONCERNS THAT THE BIOMED TEAM FOUND FLUID INGRESS AND CORROSION IN THE LVPS COULD NOT BE CONFIRMED. THE CUSTOMER DID NOT RETURN ANY PRODUCT FOR THIS INVESTIGATION. THE CUSTOMER PROVIDED 2 PICTURES THAT ARE EVIDENT OF FLUID INGRESS. HOWEVER, AN INVESTIGATION CANNOT BE PERFORMED BASED ON IMAGES AND PICTURES. A TPC SITE VISIT WAS PERFORMED HOWEVER THE FINDINGS WERE NOT CONCLUSIVE. THE CUSTOMER WAS NOTED TO BE USING THE RECOMMENDED CLEANING PRODUCTS. TPC NOTED BY REMOVING THE EXCESS CLEANER FROM THE WIPES, WHEN THIS IS DONE THE WIPE DOES NOT HAVE THE ENOUGH SATURATION TO ALLOW THE DEVICE TO REMAIN VISIBLY WET FOR THE REQUIRED 3 MINUTES TO KILL C-DIFFICILE SPORES. THE FILE WAS OPENED TO DOCUMENT THE ISSUE THAT WAS REPORTED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME. THE FILE MAY BE CLOSED BASED ON THE ABOVE FACTS. 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

    IT WAS REPORTED THAT THE BIOMED TEAM FOUND FLUID INGRESS AND CORROSION ON THE LVPS. DURING THE TPC SITE VISIT IT WAS FOUND THAT THE CUSTOMER IS APPROPRIATELY CLEANING THE DEVICES WITH THE RECOMMENDED CLEANING PRODUCTS. IT WAS NOTED BY THE BD TPC THAT BD CLEANING PROCESS DESCRIBES REMOVING EXCESS FLUID FROM THE CLEANING CLOTH/WIPE, BUT WHEN THAT IS DONE THE WIPE DOES NOT HAVE ENOUGH SATURATION TO ALLOW THE DEVICE TO REMAIN VISIBLY WET FOR THE REQUIRED 3 MINUTES TO KILL C-DIFFICILE SPORES AS THE BLEACH CONTAINER DIRECTS. THERE ARE SOME QUESTIONS ON WHETHER THE CLEANING DIRECTIONS MIGHT BE ALLOWING SOME FLUID INGRESS. IT IS ALSO SUGGESTED THAT THERE MAY BE AN ISSUE WITH MISALIGNMENT OR DAMAGE OF THE O-RING THAT IS ATTACHED TO THE WIRE HARNESS AND IS INSERTED INTO THE DOOR PRIOR TO ATTACHING THE BACK OF THE PUMP MODULE DOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441360 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1