BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10807413 · Received November 9, 2020

    Report

    Report Number
    2016493-2020-33599
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Report Date
    May 31, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1360-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF CRM (B)(4) - ERROR 13-1053-149 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. REVIEW OF THE SOURCE DEVICE S/N (B)(4) SERVICE HISTORY SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 12/02/2015. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE AND INDICATED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY RETURNED FOR SERVICE. REVIEW OF THE QN DATABASE WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH PRESENT. THE DATABASE SHOWED A QUALITY NOTIFICATIONS WAS NOT OPENED FOR THE SOURCE 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. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PUMP MODULE ALARMED WITH ERROR CODE 13-1053-149 WHILE INFUSING ON A PATIENT. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275038 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1