BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 11875764 · Received May 25, 2021

    Report

    Report Number
    2016493-2021-53141
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 4, 2021
    Report Date
    April 25, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT : A1402 - EXCESS FLOW OR OVER-INFUSION (1311), B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. A REVIEW OF THE COMPLAINT HISTORY FOR THIS SERIALIZED UNIT DID NOT CONFIRM SIMILAR COMPLAINTS, BASED ON THE SAME OR RELATED FAILURE MODE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    OMIT : A2305 - MISASSEMBLED (1398), G0405211 - RETAINER, G0405213 - SCREW, G0405212 - RIVET, C1601 - ASSEMBLY PROBLEM IDENTIFIED, D11 - CAUSE TRACED TO USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD UNDERGONE OVER-INFUSION. DETAILS OF THE INFUSION : "FREE FLOWED 400 ML INTO A CHILD. INFUSION WAS D51/2NS AND BEGAN AT MIDNIGHT. BY 0130, 400 ML HAD DELIVERED TO PATIENT WHICH WAS 368.4 ML OVER THE PROGRAMMED RATE AND DOSE". THERE WAS A PATIENT INVOLVEMENT BUT NO HARM CAUSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD UNDERGONE OVER-INFUSION. DETAILS OF THE INFUSION : "FREE FLOWED 400 ML INTO A CHILD. INFUSION WAS D51/2NS AND BEGAN AT MIDNIGHT. BY 0130, 400 ML HAD DELIVERED TO PATIENT WHICH WAS 368.4 ML OVER THE PROGRAMMED RATE AND DOSE". THERE WAS A PATIENT INVOLVEMENT BUT NO HARM CAUSED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD UNDERGONE OVER-INFUSION. DETAILS OF THE INFUSION : "FREE FLOWED 400 ML INTO A CHILD. INFUSION WAS D51/2NS AND BEGAN AT MIDNIGHT. BY 0130, 400 ML HAD DELIVERED TO PATIENT WHICH WAS 368.4 ML OVER THE PROGRAMMED RATE AND DOSE". THERE WAS A PATIENT INVOLVEMENT BUT NO HARM CAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772935 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015| 8015| 8100| 8100| 8110| 8110| 8015.| 8100.| 8110.