BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11085506 · Received December 29, 2020

    Report

    Report Number
    2016493-2020-83100
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Report Date
    November 26, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1361-2020
    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 RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    ERROR CODE 13-1033-149. IUI- CONTAMINATION. DAMAGED/CRACKED- BARREL CLAMP ASSY. , CASE REAR, CASE FRONT. SOFT FAULT- 13 1033 149. THERE WAS NO PATIENT INVOLVEMENT. ERROR CODE 13-1033-149- (B)(4). SHIPPING & BILLING ADDRESSES CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551138 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1