BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11720759 · Received April 23, 2021

    Report

    Report Number
    2016493-2021-503698
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Report Date
    April 13, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF NPI 8100 ERROR SMX NULL PTR REF (B)(4). TECHNICAL SUPPORT: 1. INFORMED CUSTOMER THIS IS MOST LIKELY DUE TO THE LOGIC BOARD. 2. CUSTOMER IS UNABLE TO DOWNLOAD AND EXPORT EVENT LOGS. 3. INFORMED CUSTOMER CAD WILL BE IN CONTACT WITH FURTHER INSTRUCTIONS. 4. CALLED TO VERIFY CAD HAS BEEN IN CONTACT. 5. LEFT A MESSAGE REQUESTING A CALL BACK. 6. LEFT FINAL MESSAGE REQUESTING CALL BACK IF CAD HAS NOT BEEN IN TOUCH. 7. INFORMED THE CASE WILL BE CLOSED IF NO CALL BACK IS RECEIVED. TECHNICAL SUPPORT CASE WILL NOW BE CLOSED. THE PROXIMATE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ERROR MESSAGE. THE ERROR DISPLAYED WAS SMX NULL PTR REF (B)(4) WHEN ATTACHING THE 8100 TO AN 8015. THE TECH RECOMMENDED REPLACING THE LOGIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ERROR MESSAGE. THE ERROR DISPLAYED WAS SMX NULL PTR REF 16-14-181 WHEN ATTACHING THE 8100 TO AN 8015. THE TECH RECOMMENDED REPLACING THE LOGIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615959 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1