BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV CKV 3 SS 20DP 20PK

    MDR report key: 10336459 · Received July 28, 2020

    Report

    Report Number
    9616066-2020-02332
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 13, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203020992
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE PHOTO, THE REPORTED INCIDENT OF THE PRIMARY TUBING FUSING COULD NOT BE VERIFIED DUE TO THE PHOTO BEING UNCLEAR. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2426-0500 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. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED. ROOT CAUSE DESCRIPTION: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM V/NV CKV 3 SS 20DP 20PK WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A SET OF PRIMARY TUBING TO REPORT. ON 7/10 WE HAD A SET OF PRIMARY TUBING FUSED TOGETHER. UNFORTUNATELY, ALL I HAVE IS A PICTURE AND IT IS DIFFICULT TO SEE. I HAVE ALREADY OPENED ONE CASE WITH THIS SAME ISSUE THAT INVOLVED BLOOD TUBING. THIS IS THE FIRST WITH PRIMARY TUBING. CAN YOU VERIFY THAT THE PRODUCT NUMBER IS 2426-0500? YES. WHAT WAS THE LOT NUMBER OF THE BD ALARIS¿ PUMP MODULE ADMINISTRATION SET? UNKNOWN. WAS THERE AN ADVERSE EVENT THAT OCCURRED AT THE TIME OF REPORTED DEFECT? NO. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? DURING PRIMING IT WAS NOTICED; IT WAS DURING ADMINISTRATION OF CHEMO. IT WAS PROGRAMMED ON THE PUMP AND WHENEVER WE STARTED, THE PUMP STARTED BEEPING, STATING AIR IN LINE AND OCCLUDED. THEN WE NOTICED TUBING MALFUNCTION. THESE MALFUNCTIONS IN THE TUBING ARE PUTTING OUR STAFF AND PATIENTS AT RISK OF SPILLING HAZARDOUS MATERIAL (CHEMOTHERAPY) CAUSING UNNECESSARY EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795148 GEM V/NV CKV 3 SS 20DP 20PK INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN 07613203020992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other