BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11130354 · Received January 7, 2021

    Report

    Report Number
    2016493-2021-02724
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    January 17, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    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 REPORTED PROBLEM WAS CONFIRMED. 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 #: 00961300 CASE SUBJECT: NPI 8110 FAILING BARREL CLAMP TEST ACCOUNT NAME: CHILDRENS HOSPITAL KINGS DAUGHTERS ACCOUNT #: 1103400 ASSET NAME: 8110 SYRINGE MODULE V8.5.6 R ASSET LOCATION: CONTACT: NATE WESTRICK CONTACT EMAIL: CONTACT PHONE: 804-628-7000 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: CUSTOMER CALLED REPORTING THEIR 8110 (SN: (B)(4)) FAILING THE BARREL CLAMP PM. FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: - RECOMMENDED CUSTOMER REPLACE SIZER ASSEMBLY. - PROVIDED PART NUMBER FOR SIZER ASSEMBLY. - CUSTOMER WILL MOST LIKELY ORDER SIZER ASSEMBLY. ENDED CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33713 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1