BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV 20D 1CV 2SS DEHP FREE

    MDR report key: 11373660 · Received February 24, 2021

    Report

    Report Number
    9616066-2021-50292
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 28, 2021
    Report Date
    March 4, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE RETURN TO MANUFACTURER?: YES. D.10 RETURNED TO MANUFACTURER ON: 2021-02-18. H.6 INVESTIGATION SUMMARY: ONE SAMPLE OF PRIMARY INFUSION SET MODEL 2420-0007 WITH A DIFFERENT MANUFACTURER'S SECONDARY SET AND A DIFFERENT MANUFACTURER'S EXTENSION SET WITH FILTER. THE CUSTOMERS COMPLAINT OF FLUID BLOCKAGE COULD NOT BE VERIFIED WITH THE PRIMARY SET BY ITSELF. THE PRIMARY INFUSION SET WAS PRIMED AND OBSERVED FOR ANY DEFECTS OR DAMAGES TO THE COMPONENTS AND TUBING. NO ISSUES WERE OBSERVED. A SIMULATED INFUSION WAS THEN CONDUCTED WITH THE PRIMARY INFUSION SET AND AN ALARIS PUMP WITH AN INFUSION RATE OF 125 ML/HR. NO ISSUES WERE OBSERVED WITH THE SIMULATED INFUSION WITH THE PRIMARY SET BY ITSELF. THE SECONDARY SET FROM UNKNOWN MANUFACTURER WAS THEN PRIMED AND CONNECTED TO THE PRIMARY SET. NO ADDITIONAL ISSUES WERE OBSERVED WITH THE SECONDARY SET CONNECTED TO THE PRIMARY SET. THE EXTENSION SET FROM AN UNKNOWN MANUFACTURER WAS THEN CONNECTED TO THE PRIMARY INFUSION SET AND AN OCCLUSION ERROR WAS INDICATED ON THE ALARIS PUMP. FURTHER INVESTIGATION OF THE EXTENSION SET INDICATES THAT THE EXTENSION SET WAS NOT ALLOWING FOR FLOW THOUGH THE FILTER. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2420-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE FOR THE FAILURE OBSERVED IS CAUSED BY AN ISSUE WITH AN EXTENSION SET WITH FILTER THAT WAS NOT MANUFACTURED BY BD. FURTHER INVESTIGATION OF THE EXTENSION SET WOULD NEED TO BE CONDUCTED BY ITS MANUFACTURER IN ORDER FOR THE CAUSE OF THE FAILURE TO BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2420-0007 AND BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE PUMP ALARMED THAT THE LINE WAS OCCLUDED, DESPITE TROUBLE SHOOTING THE CENTRAL LINE.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER FACILITY NAME: (B)(6). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2420-0007, BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE PUMP ALARMED THAT THE LINE WAS OCCLUDED, DESPITE TROUBLE SHOOTING THE CENTRAL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268935 GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1