BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM V/NV CKV 3 SS 20DP 20PK

    MDR report key: 10646031 · Received October 7, 2020

    Report

    Report Number
    9616066-2020-20024
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 13, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203021006
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/7/2020. H.6. INVESTIGATION: THE CUSTOMER PROVIDED 3 REPRESENTATIVE SAMPLES OF THE AFFECTED SAMPLES CONTAINING THE SAME MATERIAL (2426-0500) AND LOT NUMBER (20053462). ALL THREE SAMPLES WERE VISUALLY INSPECTED, SETUP FOR PRIMING, AND DID NOT LEAK OR HAVE ANY OTHER ISSUES. THE CUSTOMER COMPLAINT OF SEPARATION AT THE SMARTSITE Y-PORT WAS NOT VERIFIED AFTER RECREATING THE CIRCUMSTANCE WITH REPRESENTATIVE SAMPLES. SINCE NO ISSUE WAS FOUND, A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0500 LOT NUMBER 20053462 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV CKV 3 SS 20DP 20PK EXPERIENCED COMPONENT SEPARATION AND LEAKAGE WHICH RESULTED IN THE DEVICE OPERATOR BEING EXPOSED TO CHEMOTHERAPY AGENT. NO INFORMATION HAS BEEN PROVIDED SPECIFYING WHETHER MEDICAL INTERVENTION WAS APPLIED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER ALARIS PUMP INFUSION SET BACK CHECK VALVE 3 SMARTSITE Y-SITES PRIMARY TUBING MALFUNCTION SEPTEMBER 16TH, 2020. THIS TIME THIS MALFUNCTION RESULTED IN A CHEMO SPILL AND UNFORTUNATELY A STAFF MEMBER WAS EXPOSED. IT WAS REPORTED THAT AN INFUSION OF ABRAXANE (HAZARDOUS CYTOTOXIC) WAS RUNNING, WHICH IS A SMALL BAG CHEMO. IN ORDER TO ADMINISTER THE ENTIRE AMOUNT, THE STAFF HAVE TO CLAMP THE PRIMARY LINE. THE PRIMARY TUBING DISCONNECTED FROM ITSELF AT THE FIRST Y-SITE. THE NURSE WAS EXPOSED TO FLUID ON HER SKIN. ONE OF OUR EDUCATORS WAS ABLE TO GET A PICTURE OF THE TUBING. INCIDENT REPORTS HAVE BEEN COMPLETED. PRODUCT NUMBER 2426-0500. THE LOT NUMBER OF THE TUBING WAS 20053462.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM V/NV CKV 3 SS 20DP 20PK EXPERIENCED COMPONENT SEPARATION AND LEAKAGE, WHICH RESULTED IN THE DEVICE OPERATOR BEING EXPOSED TO CHEMOTHERAPY AGENT. NO INFORMATION HAS BEEN PROVIDED SPECIFYING WHETHER MEDICAL INTERVENTION WAS APPLIED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER ALARIS PUMP INFUSION SET BACK CHECK VALVE 3 SMARTSITE Y-SITES PRIMARY TUBING MALFUNCTION ON (B)(6) 2020. THIS TIME THIS MALFUNCTION RESULTED IN A CHEMO SPILL AND UNFORTUNATELY A STAFF MEMBER WAS EXPOSED. IT WAS REPORTED THAT AN INFUSION OF ABRAXANE (HAZARDOUS CYTOTOXIC) WAS RUNNING, WHICH IS A SMALL BAG CHEMO. IN ORDER TO ADMINISTER THE ENTIRE AMOUNT, THE STAFF HAVE TO CLAMP THE PRIMARY LINE. THE PRIMARY TUBING DISCONNECTED FROM ITSELF AT THE FIRST Y-SITE. THE NURSE WAS EXPOSED TO FLUID ON HER SKIN. ONE OF OUR EDUCATORS WAS ABLE TO GET A PICTURE OF THE TUBING. INCIDENT REPORTS HAVE BEEN COMPLETED. PRODUCT NUMBER: 2426-0500; THE LOT NUMBER OF THE TUBING WAS 20053462.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110792 GEM V/NV CKV 3 SS 20DP 20PK INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2426-0500 20053462 37613203021006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other