BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 13425256 · Received February 2, 2022

    Report

    Report Number
    9616066-2022-00058
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    November 11, 2021
    Report Date
    February 3, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203012448
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE - NO LEAK COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ALARIS PUMP MODULE SMARTSITE INFUSION SET A PART OF THE DEVICE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAT# 2420-0500. LOT NUMBER: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE MALE END OF THE INFUSION SET SNAPPED AND REMAIN STUCK INSIDE THE PROXIMAL PORT OF THE CENTRAL VENOUS CATHETER. VERBATIM: ISD- WRITER WAS DISCONNECTING ALARIS PUMP INFUSION SET FROM AN ARROW MULTI LUMEN CENTRAL VENOUS CATHETER INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN, AND THE MALE END OF THE INFUSION SET SNAPPED AND REMAIN STUCK INSIDE THE PROXIMAL PORT OF THE CENTRAL VENOUS CATHETER. CHARGE RN AND MEDICAL TEAM WAS MADE AWARE OF THIS OCCURRENCE, AND MEDICAL TEAM ATTEMPTED TO REMOVE THE STUCK PORTION OF THE INFUSION SET UNDER STERILE TECHNIQUE. UNABLE TO SUCCESSFULLY REMOVE THE LODGED END.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ALARIS PUMP MODULE SMARTSITE INFUSION SET A PART OF THE DEVICE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAT# 2420-0500 LOT NUMBER: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE MALE END OF THE INFUSION SET SNAPPED AND REMAIN STUCK INSIDE THE PROXIMAL PORT OF THE CENTRAL VENOUS CATHETER. VERBATIM: ISD- WRITER WAS DISCONNECTING ALARIS PUMP INFUSION SET FROM AN ARROW MULTI LUMEN CENTRAL VENOUS CATHETER INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN, AND THE MALE END OF THE INFUSION SET SNAPPED AND REMAIN STUCK INSIDE THE PROXIMAL PORT OF THE CENTRAL VENOUS CATHETER. CHARGE RN AND MEDICAL TEAM WAS MADE AWARE OF THIS OCCURRENCE, AND MEDICAL TEAM ATTEMPTED TO REMOVE THE STUCK PORTION OF THE INFUSION SET UNDER STERILE TECHNIQUE. UNABLE TO SUCCESSFULLY REMOVE THE LODGED END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296863 ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2420-0500 UNKNOWN 37613203012448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown