BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 23795343 · Received December 12, 2025

    Report

    Report Number
    9616066-2025-03765
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 4, 2025
    Report Date
    March 18, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K221327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RECEIVED FOR QUALITY EVALUATION. VISUAL INSPECTION OF THE THE SAMPLE INDICATES THAT THE ROLLER CLAMP IS CRUSHED AND THE PINCH ROLLER OF THE CLAMP IS MISSING. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE WAS CONFIRMED. THE INVESTIGATION WAS FORWARDED TO THE MANUFACTURING GROUP TO REVIEW THE DAMAGE TO DETERMINE IF THE DAMAGE WAS CAUSED DURING MANUFACTURING. AFTER THE INVESTIGATION, MANUFACTURING DETERMINED THAT THE DAMAGE COULD NOT BE REPLICATED DURING ANY PORTION OF THE ASSEMBLY PROCESS. THE PERSONNEL INVOLVED IN THE SET ASSEMBLY PROCESS WERE NOTIFIED ABOUT THE REPORTED ISSUE. THEY WERE INSTRUCTED TO INFORM THEIR SUPERVISOR IF ANY DAMAGED COMPONENT IS IDENTIFIED PRIOR TO ASSEMBLY. THE INVESTIGATION WAS THEN FORWARDED TO THE SUPPLIER QUALITY GROUP TO DETERMINE IF THE COMPONENT COULD HAVE BEEN RECEIVED DAMAGED IN THE MATTER OBSERVED. THE SUPPLIER QUALITY TEAM DETERMINED THAT THE TYPE OF DAMAGE SEEN COULD NOT BE DUE TO THE SUPPLIER DUE TO MULTIPLE CHECKS OF THE COMPONENTS BEFORE THEY ARE INSTALLED IN THE ASSEMBLY. THE ROOT CAUSE FOR THE DAMAGE SEEN IS UNKNOWN. THE POSSIBLE CAUSE OF THE ISSUE IS THAT THE COMPONENT MAY HAVE BEEN DAMAGED DURING TRANSPORT OF THE PRODUCT. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 24113241 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD A DAMAGED CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ROLLER CLAMP THUMB ROLLER MISSING WITH PLASTIC CARTRIDGE COMPRESSED. BRAND NEW TUBING TAKEN OUT OF THE PACKAGE. DESCRIPTION OF PRODUCT: GEM V/NV 20D 1CV 2SS DEHP-FREE 20EA/CA. LOT OR S/N: (B)(6), PATIENT INJURY: NO, QTY AFFECTED: 1 EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762087 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 24113241 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown