BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11052974 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-75521
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    October 15, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. BASED ON THE FILE REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE #: 00870267 CASE SUBJECT: NPI 8110 ERROR 13-1033-149 ACCOUNT NAME: US MEDEQUIP ACCOUNT #: 1021373 ASSET NAME: 8110 SYRINGE MODULE, V8 ASSET LOCATION: CONTACT: (B)(6) CONTACT EMAIL: (B)(6) CONTACT PHONE: (B)(6) CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: CALLER HAS A 8110 MODULE GIVING A 13-1033-149 ERROR. SN: (B)(4) FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8110 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: RECOMMENDED TO REFLASH THE SOFTWARE TO TRY TO CLEAR THE ERROR. IF FLASHING FAILS, THE LOGIC BOARD WILL HAVE TO BE REPLACED. LET HIM KNOW IT SEND IN UNIT UNDER FLAT RATE LEVEL 1 REPAIR DUE TO THE COST OF THE LOGIC BOARD. BIOMED ENDED CALL AND WILL CALL BACK IF FURTHER ASSISTANCE IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509611 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1