BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET

    MDR report key: 15658088 · Received October 24, 2022

    Report

    Report Number
    9616066-2022-01591
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 4, 2022
    Report Date
    November 11, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203021143
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED BY THE CUSTOMER THAT SMOF LIPIDS PAUSED TO INFUSE MEDICATION DUE TO INCOMPATIBILITY AND THEN RESTARTED 15 MINUTES LATER AND INFUSION PUMP STATING 'OCCLUDED-PATIENT SIDE. PATIENT ACCESS AND TUBING AND BLUE PRIMARY LIPID TUBING FOUND TO BE OCCLUDED/NOT ALLOWING FLOW PAST FILTER COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET EXPERIENCED FLOW ISSUES, AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIPIDS PAUSED TO INFUSE MEDICATION DUE TO INCOMPATIBILITY AND THEN RESTARTED 15MINUTES LATER AND INFUSION PUMP STATING 'OCCLUDED-PATIENT SIDE'. RN TROUBLESHOOTED PUMP, PATIENT ACCESS AND TUBING AND BLUE PRIMARY LIPID TUBING FOUND TO BE OCCLUDED/NOT ALLOWING FLOW PAST FILTER. TUBING DISCONNECTED FROM PATIENT AND SAQ RN AND CHARGE RN NOTIFIED. NO HARM TO PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET EXPERIENCED FLOW ISSUES, AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIPIDS PAUSED TO INFUSE MEDICATION DUE TO INCOMPATIBILITY AND THEN RESTARTED 15 MINUTES LATER AND INFUSION PUMP STATING 'OCCLUDED-PATIENT SIDE'. RN TROUBLESHOOTED PUMP, PATIENT ACCESS AND TUBING AND BLUE PRIMARY LIPID TUBING FOUND TO BE OCCLUDED/NOT ALLOWING FLOW PAST FILTER. TUBING DISCONNECTED FROM PATIENT AND SAQ RN AND CHARGE RN NOTIFIED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821575 BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10010453 UNKNOWN 37613203021143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown