BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 13927941 · Received March 28, 2022

    Report

    Report Number
    2016493-2022-121848
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    March 10, 2022
    Report Date
    May 16, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Additional Manufacturer Narrative · 0

    CORRECTION: DISREGARD THE INITIAL REPORT MFR REPORT # 2016493-2022-121848. AFTER FURTHER REVIEW OF THE FILE IT WAS DETERMINED THAT THIS FILE IS NOT A REPORTABLE COMPLAINT AND THE MDR WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE VENT. [REPAIR MULTI-DEVICE];[MMS-20-3817 LVP KEYPAD REPLACEMENT P2.MMS-20-3818 SYRINGE BARREL CLAMP REPLACEMENT P2.MMS-20-1953 SOFTWARE RECALL V12.1.1]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE VENT. [REPAIR MULTI-DEVICE];[MMS-20-3817 LVP KEYPAD REPLACEMENT P2 MMS-20-3818 SYRINGE BARREL CLAMP REPLACEMENT P2 MMS-20-1953 SOFTWARE RECALL V12.1.1]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879747 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown