BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET

    MDR report key: 11802881 · Received May 10, 2021

    Report

    Report Number
    9616066-2021-50944
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    March 24, 2021
    Report Date
    July 13, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED FOR INVESTIGATION BY THE CUSTOMER. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS PRIMED WITH SALINE AND INFUSED WITH BD ALARIS PUMP DCHU - 0010 WITH PUMP MODULE DCHU-0016 AT 525 ML/HR FOR 1 HOUR. THE INFUSION RUN COMPLETED SUCCESSFULLY. THE CUSTOMER COMPLAINT THAT A PATIENT WAS RECEIVING 525 ML OF ERBITUX, OVER 60 MINUTES AND FOR THE LAST 20CC THE PUMP DETECTED THE OCCLUSION IN THE TUBING COULD NOT BE REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW FOR MODEL (B)(4) LOT NUMBER 20116927 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 4TH RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FLOW ISSUES - FLUID BLOCKAGE WITH LOT #20116927 REGARDING ITEM #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET EXPERIENCED FLOW ISSUES, AND WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(4) BATCH NO: 20116927. WE CAME ACROSS AN ISSUE ON A TUBING SET .THE PATIENT WAS RECEIVING 1050 MG OF ERBITUX, WHICH WAS 525 ML OVER 60 MINUTES. THE IV BAG WAS INFUSING SUCCESSFULLY WITH NO ISSUES UNTIL IT CAME DOWN TO THE LAST 20CC. THE INFUSION WAS STOPPED BY THE ALARIS PUMP AND READ THAT THERE WAS AN OCCLUSION IN THE TUBING. THE NURSE INSPECTED THE TUBING AND THE IV BAG AND DID NOT WITNESS ANY OCCLUSION. THE NURSE ATTEMPTED TO INFUSE A SEPARATE NEW IV BAG THROUGH THE SAME ALARIS PUMP LINE, AND THE INFUSION WAS FLOWING THROUGH WITH NO ISSUES. THE NURSE ALSO TRIED TO INFUSE THE DEFECTIVE ERBITUX IV BAG THROUGH A DIFFERENT ALARIS PUMP LINE, BUT IT STILL WAS NOT FLOWING. THEREFORE, THERE WERE NO ISSUES WITH THE ALARIS PUMP. OUR CORRECTIVE ACTION PLAN THIS TIME WAS TO CHANGE THE TUBING, AND THE INFUSION WAS ADMINISTERED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH #: 5100336. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET EXPERIENCED FLOW ISSUES, AND WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 24301-0007T. BATCH NO: 20116927. WE CAME ACROSS AN ISSUE ON A TUBING SET .THE PATIENT WAS RECEIVING 1050 MG OF ERBITUX, WHICH WAS 525 ML OVER 60 MINUTES. THE IV BAG WAS INFUSING SUCCESSFULLY WITH NO ISSUES UNTIL IT CAME DOWN TO THE LAST 20CC. THE INFUSION WAS STOPPED BY THE ALARIS PUMP AND READ THAT THERE WAS AN OCCLUSION IN THE TUBING. THE NURSE INSPECTED THE TUBING AND THE IV BAG AND DID NOT WITNESS ANY OCCLUSION. THE NURSE ATTEMPTED TO INFUSE A SEPARATE NEW IV BAG THROUGH THE SAME ALARIS PUMP LINE, AND THE INFUSION WAS FLOWING THROUGH WITH NO ISSUES. THE NURSE ALSO TRIED TO INFUSE THE DEFECTIVE ERBITUX IV BAG THROUGH A DIFFERENT ALARIS PUMP LINE, BUT IT STILL WAS NOT FLOWING. THEREFORE, THERE WERE NO ISSUES WITH THE ALARIS PUMP. OUR CORRECTIVE ACTION PLAN THIS TIME WAS TO CHANGE THE TUBING, AND THE INFUSION WAS ADMINISTERED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694935 ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20116927

    Patients

    Seq Age Sex Outcome Treatment
    1