BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10826954 · Received November 11, 2020

    Report

    Report Number
    2016493-2020-37026
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Report Date
    June 7, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF IUI CORROSION 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. ALTHOUGH NO DEVICES WERE PROVIDED FOR INVESTIGATION, THE SITE VISIT SUMMARY CONTAINS PHOTOS THAT CONFIRM THE CUSTOMER¿S GENERALIZED REPORT. AN INVESTIGATION CAN¿T BE PERFORMED USING THE ATTACHED PHOTO 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. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING A CPC SITE VISIT CORRODED IUI'S. IT WAS FOUND DURING THE CPC SITE VISIT THAT THERE ARE TWO DEPARTMENTS RESPONSIBLE FOR CLEANING THE DEVICES. THE TRANSPORT TEAM AND THE EVS DEPARTMENT. THE EVS DEPARTMENT IS RESPONSIBLE FOR CLEANING THE DEVICES THAT ARE LOCATED IN A ROOM ONCE THE PATIENT HAS BEEN DISCHARGED, THE TRANSPORT TEAM CLEANS ALL OTHERS. IN DEMONSTRATION, THE TRANSPORT TEAM MANAGER CLEANED THE DEVICES WITH PDI BLEACH WIPES WHICH INCLUDED WIPING DIRECTLY OVER THE IUI CONNECTORS, THOROUGHLY, WIPING THE ENTIRE CASE, AND INSIDE THE LVP DOOR. THE PUMPS ARE THEN STORED IN THEIR DEPO WITH SOME OF THEM PLUGGED IN AND OTHERS NOT DUE TO LIMITED AC OUTLETS. THE EVS MANAGER STATED THAT THEY ALSO USE THE PDI BLEACH WIPES AND WIPE OVER THE ENTIRE CASE, INCLUDING THE IUI CONNECTORS. ONCE THE DEVICE HAS BEEN CLEANED, IT IS IMMEDIATELY BAGGED AND PLUGGED IN. IT WAS NOTED THAT NEITHER TEAM REMOVED THE CLEANING SOLUTION AFTER CLEANING AND THE BLEACH FILM WAS OBSERVED ON ALL DEVICES. THE BIOMED DEPARTMENT WAS VERY KNOWLEDGEABLE AND WAS AWARE OF THE BLEACH WIPES TO THE IUI CONNECTORS AND CONNECTED THIS TO THE FREQUENT CHANNEL DISCONNECTS. ON A SIDE NOTE, THE PCU'S ARE RENTED AND THE LVPS ARE OWNED BY THE FACILITY. ADDITIONALLY, THE DEVICES HAVE ONE LVP BOLTED TO THE RIGHT OF THE PCU AND NEITHER EVS OR THE TRANSPORT TEAM DETACH THE LVP FOR CLEANING PURPOSES. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286565 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1