BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 17919335 · Received October 12, 2023

    Report

    Report Number
    9616066-2023-02060
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    October 9, 2023
    Report Date
    January 3, 2024
    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
    NY, 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 THAT THERE WAS A SEPARATION COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 23025193 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 11FEB2023. 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. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THERE WAS A SEPARATION COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 23025193 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 20JUL2023. 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. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    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

    MATERIAL #: 2420-0007 BATCH #: 23025193, 23075292. IT WAS REPORTED BY CUSTOMER THAT THEY VERY CONCERNED AS OVER THE LAST SIX WEEKS, WE HAVE HAD A SEEMINGLY STEADY INCREASE IN IV TUBING COMING APART. BOTH SECONDARY AND PRIMARY LINES HAVE COME APART UNDER THE DRIP CHAMBER. WE HAVE HAD MULTIPLE CHEMO SPILLS AS A RESULT. VERBATIM: THERE CURRENTLY ISN¿T AN OPTION IN RL SOLUTIONS TO INCLUDE THE SUPPLY CHAIN TEAM. (B)(6) OVERSEES RL SOLUTION REPORTS FOR WCI. PERHAPS SHE COULD HELP GET THAT OPTION IN RL? IS THERE SOMEONE ELSE WE CAN ASSIGN THESE TO OR IS THERE A SPECIFIC DEPARTMENT NAME USED FOR SUPPLY CHAIN TEAM? I AM VERY CONCERNED AS OVER THE LAST SIX WEEKS, WE HAVE HAD A SEEMINGLY STEADY INCREASE IN IV TUBING COMING APART. BOTH SECONDARY AND PRIMARY LINES HAVE COME APART UNDER THE DRIP CHAMBER. WE HAVE HAD MULTIPLE CHEMO SPILLS AS A RESULT. SEE THE PHOTO BELOW CIRCLED WHERE THE TUBING CAME APART. BD CHEMO SECONDARY SET CATALOG NUMBER 10013364T. LOT NUMBERS: (10) 235059177 EXP. DATE 5/23/2026. (10) 10016073, (10) 23039137. PRIMARY TUBING CATALOG NUMBER 2420-0007. LOT NUMBER: (10) 23025, EXP. DATE 2/7/2026. (10) 23075292. UPON VISUAL INSPECTION, STAFF HAVE NOTICED THAT THERE IS A KINK THERE AT TIMES BUT NOT ALWAYS. STAFF UNKINK THE TUBING AND THE TUBING APPEARS IN TACT WITH MINOR MANIPULATION (CLAMPING AND UNCLAMPING). IT ALMOST ALWAYS COMES APART CHAIRSIDE, AS THE NURSE IS RAISING THE BAG TO HANG IT. THE NURSES HAVE BEEN THE ONES THE CHEMO IS SPILLING ON PRIMARILY -SOAKING THEIR SHOES AND SOCKS. I HAVE REINFORCED WITH STAFF TO PLEASE KEEP IN MIND WHEN USING ANY PRODUCT/TUBING TO INSPECT BEFORE USING. I AM ENCOURAGING STAFF THAT INSPECTING INCLUDE GENTLY TUGGING AT THE TUBING, LOOKING FOR KINKS AND SEEING IF THERE IS A COMPROMISE TO THE INTEGRITY OF THE PRODUCT. IF A PRODUCT IS QUESTIONABLE FOR USE OR THERE IS COMPROMISE, NOT TO USE AND FILL OUT AN RL SOLUTION - INCLUDE THE LOT NUMBER OF THE PRODUCT IF AVAILABLE. ALSO, SAVE (UNUSED) PRODUCT IN A BAG AND LABEL DEFECTIVE IN THE CASE SOMEONE REACHES OUT FOR IT FOR FURTHER ANALYSIS. I HAVE NOTIFIED REGIONAL PHARMACY, NURSING LEADERSHIP FROM WCI REGIONAL TEAM AND WCI MAIN CAMPUS ¿ INPATIENT AND OUTPATIENT DUE TO THE CONCERN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: I AM VERY CONCERNED AS OVER THE LAST SIX WEEKS, WE HAVE HAD A SEEMINGLY STEADY INCREASE IN IV TUBING COMING APART. BOTH SECONDARY AND PRIMARY LINES HAVE COME APART UNDER THE DRIP CHAMBER. WE HAVE HAD MULTIPLE CHEMO SPILLS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143387 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23075292 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown