BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP

    MDR report key: 11741319 · Received April 28, 2021

    Report

    Report Number
    2016493-2021-503864
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Report Date
    April 21, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1360-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. TECHNICAL SUPPORT PERFORMED, TROUBLESHOOTING OVER THE PHONE TO DETERMINE, THE CUSTOMER REPORTED ISSUE OF 8110 ERROR CODE 13-1033-149. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT DETERMINED, THE PROBABLE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE SOFTWARE/LOGIC BOARD ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED, THE DEVICE HAD A MANUFACTURE DATE OF 21FEB2014. THE REVIEW WAS PERFORMED, FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED. WHICH CONFIRMED, THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE. WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED. WHICH DID NOT CONFIRM, SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE DEVICE RECEIVED AN ALARM ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 13-1033-149. THE TECH RECOMMENDED, REFLASHING THE SOFTWARE AND REPLACING THE LOGIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 13-1033-149. THE TECH RECOMMENDED RE-FLASHING THE SOFTWARE AND REPLACING THE LOGIC BOARD. 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 AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 13-1033-149. THE TECH RECOMMENDED RE-FLASHING THE SOFTWARE AND REPLACING THE LOGIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635728 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1