BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG ACCESS DEVICE W/CKV

    MDR report key: 11143927 · Received January 9, 2021

    Report

    Report Number
    9616066-2020-20743
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Date of Event
    December 13, 2020
    Report Date
    December 17, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203011663
    PMA / PMN Number
    K970485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A COMPLAINT OF A DAMAGED COMPONENT WAS RECEIVED FROM THE CUSTOMER. TWO SAMPLES WERE PROVIDED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, ONE SAMPLE HAD A MISASSEMBLED CHECK VALVE, THE OTHER DID NOT HAVE ANY NOTICEABLE DEFECTS. THE TWO SAMPLES WERE THEN PRIMED. THE MISASSEMBLED SAMPLE COULD NOT BE PRIMED DUE TO FLUID NOT BEING ABLE TO FLOW THROUGH SET. THE OTHER SAMPLE WAS SUCCESSFULLY PRIMED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2309E LOT NUMBER 20076260 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 25JUL2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. INVESTIGATION CONCLUSION: THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE FOR THIS DEFECT IS AN ERROR DURING THE ASSEMBLY PROCESS OF THE SET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BAG ACCESS DEVICE W/CKV WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2309E BATCH/ LOT #: 20076260 ((B)(4) PROVIDED BUT INVALID). IT WAS REPORTED THAT ONCE THE IV BAG IS SPIKED WITH THE SMARTSITE BAG ACCESS DEVICE, THE NURSE CANNOT PULL BACK FLUID FROM THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40547 BAG ACCESS DEVICE W/CKV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2309E 20076260 37613203011663

    Patients

    Seq Age Sex Outcome Treatment
    1