BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11981280 · Received June 11, 2021

    Report

    Report Number
    2016493-2021-508063
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Report Date
    July 9, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE OF PCU FRONT CASE KEYPAD MODULES WILL BE REPLACED DUE TO NO POWER IS CONFIRMED BASED ON THE FIELD ACTION. NO FURTHER COMPLAINT INVESTIGATION IS NECESSARY AS CAPA PR 1120033 WAS OPENED TO ADDRESS THIS ISSUE. NO DEVICE HISTORY OR QN SEARCH WAS PERFORMED SINCE NO SOURCE DEVICE SERIAL NUMBER WAS REPORTED BY THE CUSTOMER. THE DEVICE IS USED FOR TREATMENT PURPOSES. 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 · 0

    IT WAS REPORTED THAT THERE WERE 10 MORE KEYPAD ISSUES TO REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF PCU FRONT CASE KEYPAD MODULES WILL BE REPLACED DUE TO NO POWER IS CONFIRMED BASED ON THE FIELD ACTION. NO FURTHER COMPLAINT INVESTIGATION IS NECESSARY AS CAPA PR 1120033 WAS OPENED TO ADDRESS THIS ISSUE. NO DEVICE HISTORY OR QN SEARCH WAS PERFORMED SINCE NO SOURCE DEVICE SERIAL NUMBER WAS REPORTED BY THE CUSTOMER. THE DEVICE IS USED FOR TREATMENT PURPOSES. 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. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 10 MORE KEYPAD ISSUES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881950 8015 ALARIS SYSTEM PC UNIT PUMP,INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other