BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE INFUSION SET

    MDR report key: 17027036 · Received May 30, 2023

    Report

    Report Number
    9616066-2023-01037
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 5, 2023
    Report Date
    June 12, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403274037
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE LEAK - CRACK COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2202-0007 LOT NUMBER 23015346 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

    B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE INFUSION SET TUBING CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CRACKED AND LEAKING" D1: MEDICAL DEVICE BRAND NAME: BD ALARIS PUMP MODULE INFUSION SET D4: UDI #: (B)(4). D4: CATALOG #: 2202-0007 . D4: MEDICAL DEVICE LOT #: 23015346. D4: MEDICAL DEVICE EXPIRATION DATE: 16-JAN-2026. H4: DEVICE MANUFACTURE DATE: 13-JAN-2023. G.5. PMA / 510(K)#: K944320.

    Additional Manufacturer Narrative · 0

    H.3. 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 PUMP MODULE INFUSION SET TUBING CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CRACKED AND LEAKING".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE INFUSION SET TUBING CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CRACKED AND LEAKING"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ BLOOD INFUSION SET TUBING CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CRACKED AND LEAKING"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185990 BD ALARIS PUMP MODULE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2202-0007 23015346 50885403274037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown