BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE BLOOD INFUSION SET

    MDR report key: 21092753 · Received January 7, 2025

    Report

    Report Number
    9616066-2024-02211
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    November 14, 2024
    Report Date
    January 17, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203019460
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF SEPARATION OTHER COMPONENT - LEAK COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL# 2477-0007 AND LOT# 23115477 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 28NOV2023. 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

    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

    MATERIAL # 2477-0007, BATCH # 23115477. IT WAS REPORTED BY CUSTOMER THAT THE NURSE WAS SPIKING THE UNIT OF BLOOD WHEN SHE NOTICED BLOOD POOLING ON THE FLOOR FROM THE BLOOD COMPONENT BAG, SHE TURNED THE BAG UPRIGHT TO SEE WHERE THE BLOOD WAS COMING FROM AND NOTICED THAT THE INFUSION TUBING WAS SNAPPED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE NURSE WAS SPIKING THE UNIT OF BLOOD WHEN SHE NOTICED BLOOD POOLING ON THE FLOOR FROM THE BLOOD COMPONENT BAG, SHE TURNED THE BAG UPRIGHT TO SEE WHERE THE BLOOD WAS COMING FROM AND NOTICED THAT THE INFUSION TUBING WAS SNAPPED. THE LINE WAS NEVER ATTACHED TO THE PATIENT SO THERE WAS NO PATIENT HARM. THE PRIMARY RN WAS NOTIFIED AND THE BLOOD BANK WAS CALLED. THE NURSES REPORTED THAT THE TUBING WAS "BRITTLE AND JUST SNAPPED." THE ACTUAL TUBING WAS NOT SEQUESTERED FOR EVALUATION. ITEM# 2477-0007, LOT# 240753.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BLOOD INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE NURSE WAS SPIKING THE UNIT OF BLOOD WHEN SHE NOTICED BLOOD POOLING ON THE FLOOR FROM THE BLOOD COMPONENT BAG, SHE TURNED THE BAG UPRIGHT TO SEE WHERE THE BLOOD WAS COMING FROM AND NOTICED THAT THE INFUSION TUBING WAS SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869034 BD ALARIS PUMP MODULE SMARTSITE BLOOD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23115477 07613203019460

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male