BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET

    MDR report key: 16133307 · Received January 10, 2023

    Report

    Report Number
    9616066-2022-02177
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 19, 2022
    Report Date
    January 10, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403227998
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE LOT #: LOT WAS REPORTED; HOWEVER, THIS IS NOT A LOT # 22099539 MANUFACTURED FOR THE REPORTED CATALOG #. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET BROKE OFF INTO BAG AFTER MEETING RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE TIP THE OF TUBING BROKE OFF INTO BAG AFTER MEETING RESISTANCE. D1: MEDICAL DEVICE BRAND NAME: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET D4: CATALOG #: 2426-0007. D4: MEDICAL DEVICE LOT #: 22099539. D4: MEDICAL DEVICE EXPIRATION DATE: 28-SEP-2025. D4: UDI #: (B)(4). G.5. PMA / 510(K)#: K944320. H4: DEVICE MANUFACTURE DATE: 28-SEP-2022. D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED AND TESTED BY OUR QUALITY TEAM. THE SET WAS VISUALLY ANALYZED, AND THE BROKEN SPIKE DESCRIBED IN COMPLAINT WAS IMMEDIATELY NOTICED AND THE COMPLAINT WAS VERIFIED. THE SET WAS THEN SENT TO THE SUPPLIER OF DRIP CHAMBER AND SPIKE FOR FURTHER INVESTIGATION TO DETERMINE IF THERE WAS A POSSIBILITY OF DEFECT IN PRODUCTION. THE MANUFACTURER GUARANTEED AFTER INVESTIGATION AND ANALYSIS OF PRODUCTION RECORDS THAT THE FAILURE WAS NOT DUE TO PRODUCTION DEFICIENCIES AND THE PRODUCTION RECORDS SHOWED NO EVIDENCE OF QUALITY ISSUES RELATED TO THIS INCIDENT. THE ROOT CAUSE OF THE FAILURE IS UNKNOWN BUT CANNOT BE TRACED TO MANUFACTURING. DEVICE WAS DETERMINED TO BE A 2426-0007 AND NOT A MS3500-15 AS PREVIOUSLY REPORTED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0007 LOT NUMBER 22099539 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ SECONDARY SET TUBING BROKE OFF INTO BAG AFTER MEETING RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE TIP THE OF TUBING BROKE OFF INTO BAG AFTER MEETING RESISTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET BROKE OFF INTO BAG AFTER MEETING RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE TIP THE OF TUBING BROKE OFF INTO BAG AFTER MEETING RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195293 BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2426-0007 22099539 10885403227998

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown