BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS

    MDR report key: 17319768 · Received July 13, 2023

    Report

    Report Number
    9616066-2023-01434
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 28, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403198913
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS WERE PROVIDED BY THE CUSTOMER FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE - LEAK WAS NOT VERIFIED BY EVALUATION OF THE PHOTOS PROVIDED BY THE CUSTOMER. THE PHOTOS PROVIDED BY THE CUSTOMER DO NOT SHOW THE DAMAGE REPORTED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10013364T LOT NUMBER 22129091 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS BROKE DURING HANDLING OR TRANSPORT. REPORT 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE CUSTOMERR REPORTED THERE HAVE BEEN TWO EVENTS WITHIN THE PAST MONTH IN WHICH THE SECONDARY ADMINISTRATION SETS SUPPLIED BY CAREFUSION HAVE BROKEN EITHER DURING PRIMING THE TUBING OR DURING HANDLING/TRANSPORT OF CHEMOTHERAPY ATTACHED TO THE TUBING. HAVE THERE BEEN OTHER REPORTS OF THIS OCCURRING? BELOW ARE THE REFERENCE AND LOT NUMBERS FOR THE ADMINISTRATION SETS INVOLVED IN THE REPORTED ERRORS." RESPONSE RECEIVED ON 03-JUL-2023. ¿ DID BOTH EVENTS INVOLVE THE SAME PATIENT OR MULTIPLE PATIENT? O NEITHER EVENTS REACHED THE PATIENTS. FOR THE FIRST EVENT, THE NURSE NOTICED THE TUBING WAS BROKEN BEFORE ADMINISTERING THE CHEMOTHERAPY. FOR THE SECOND EVENT, TUBING BROKE WHILE PRIMING IT IN THE PHARMACY DURING COMPOUNDING. ¿ WHAT COMPONENT OF THE TUBING SET WAS BROKEN? O THE TUBING THAT ATTACHES TO THE PRIMING CHAMBER ¿ WAS THERE ANY LEAKAGE OBSERVED IN BOTH INCIDENTS? O YES ¿ WAS THERE ANY OTHER DEFECT OBSERVED ON THE SECONDARY SETS? O NO ¿ WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? O NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS BROKE DURING HANDLING OR TRANSPORT. REPORT 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE CUSTOMER REPORTED THERE HAVE BEEN TWO EVENTS WITHIN THE PAST MONTH IN WHICH THE SECONDARY ADMINISTRATION SETS SUPPLIED BY CAREFUSION HAVE BROKEN EITHER DURING PRIMING THE TUBING OR DURING HANDLING/TRANSPORT OF CHEMOTHERAPY ATTACHED TO THE TUBING. HAVE THERE BEEN OTHER REPORTS OF THIS OCCURRING? BELOW ARE THE REFERENCE AND LOT NUMBERS FOR THE ADMINISTRATION SETS INVOLVED IN THE REPORTED ERRORS". RESPONSE RECEIVED ON 03-JUL-2023. DID BOTH EVENTS INVOLVE THE SAME PATIENT OR MULTIPLE PATIENT? NEITHER EVENTS REACHED THE PATIENTS. FOR THE FIRST EVENT, THE NURSE NOTICED THE TUBING WAS BROKEN BEFORE ADMINISTERING THE CHEMOTHERAPY. FOR THE SECOND EVENT, TUBING BROKE WHILE PRIMING IT IN THE PHARMACY DURING COMPOUNDING. WHAT COMPONENT OF THE TUBING SET WAS BROKEN? THE TUBING THAT ATTACHES TO THE PRIMING CHAMBER WAS THERE ANY LEAKAGE OBSERVED IN BOTH INCIDENTS? YES. WAS THERE ANY OTHER DEFECT OBSERVED ON THE SECONDARY SETS? NO. WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282084 BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10013364T 22129091 50885403198913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown