BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20167175 · Received September 9, 2024

    Report

    Report Number
    2016493-2024-35534
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 15, 2024
    Report Date
    October 23, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2024-35534 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2024-35562, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCU HAD ERROR CODE MESSAGE 13-1033-149 DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO HARM. FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER WHICH STATED PC WAS ALARMING STATING "CHANNEL B ERROR 13-1033-149 AND CHANNEL A WAS ALARMING FOR COMMUNICATION ERROR". WHEN DELIVERED TO BIOMEDICAL ENGINEERING IT WAS NOTED THERE WAS "MOISTURE AND WETNESS ON THE SIDES BETWEEN THE CONNECTING PUMP BRAIN AND CHANNELS"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCU HAD ERROR CODE MESSAGE 13-1033-149 DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO HARM. FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER WHICH STATED PC WAS ALARMING STATING "CHANNEL B ERROR 13-1033-149 AND CHANNEL A WAS ALARMING FOR COMMUNICATION ERROR". WHEN DELIVERED TO BIOMEDICAL ENGINEERING IT WAS NOTED THERE WAS "MOISTURE AND WETNESS ON THE SIDES BETWEEN THE CONNECTING PUMP BRAIN AND CHANNELS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588087 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown