BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11335348 · Received February 16, 2021

    Report

    Report Number
    2016493-2021-26297
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Report Date
    February 11, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED PROBLEM WAS NOT CONFIRMED. TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER TO DETERMINE THE CUSTOMER REPORTED ISSUE OF NPI 8100 ERROR CODE 13-1033-149. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT DETERMINED THE PROXIMATE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE - SOFTWARE RELATED ISSUE. RECOMMENDED RE-FLASHING THE 8100 FIRMWARE. A SERIAL NUMBER WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER TO DETERMINE THE CUSTOMER REPORTED ISSUE OF NPI 8100 ERROR CODE 13-1033-149. TECHNICAL SUPPORT: FLASHING UNIT: 1. INFORMED CUSTOMER THIS IS A SOFTWARE RELATED ISSUE. 2. RECOMMENDED RE-FLASHING THE 8100 FIRMWARE. 3. CUSTOMER WILL FLASH UNIT. 4. CUSTOMER REPLIED BY EMAIL INFORMING FLASHING CORRECTED THE ISSUE. A SERIAL NUMBER WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT DETERMINED THE PROXIMATE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE. TECHNICAL SUPPORT: FLASHING UNIT: 1. INFORMED CUSTOMER THIS IS A SOFTWARE RELATED ISSUE. 2. RECOMMENDED RE-FLASHING THE 8100 FIRMWARE. 3. CUSTOMER WILL FLASH UNIT. 4. CUSTOMER REPLIED BY EMAIL INFORMING FLASHING CORRECTED THE ISSUE. THE CUSTOMER REPORTED PROBLEM WAS NOT CONFIRMED. H3 OTHER TEXT : NO PRODUCT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED ERROR CODE 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED ERROR CODE 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECEIVED ERROR CODE 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228007 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1