BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 14731506 · Received June 17, 2022

    Report

    Report Number
    2016493-2022-154968
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 24, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. CUSTOMER PROVIDED SAMPLE PHOTO ONLY. NO DEVICE WAS RETURNED.

    Additional Manufacturer Narrative · 0

    OMIT: A070504 - PREMATURE DISCHARGE OF BATTERY (1057), C020702 - LOSS OF POWER, G02002 - BATTERY. CORRECTION: IMDRF ANNEX A,G AND C CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOSPITAL RECEIVED TWENTY NEW PCUS AND FORTY NEW PUMP MODULES THAT WERE DELIVERED WITHIN THE PAST FEW WEEKS. HOWEVER, DURING INITIAL SETUP, SYSTEM ERROR 133.6080 DISPLAYED ON PCU. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOSPITAL RECEIVED TWENTY NEW PCUS AND FORTY NEW PUMP MODULES THAT WERE DELIVERED WITHIN THE PAST FEW WEEKS. HOWEVER, DURING INITIAL SETUP, SYSTEM ERROR 133.6080 DISPLAYED ON PCU. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350083 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown