BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ LVP BLD180M 15D SS

    MDR report key: 11096503 · Received December 30, 2020

    Report

    Report Number
    2243072-2020-02189
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    January 17, 2020
    Report Date
    October 4, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203019478
    PMA / PMN Number
    K894842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE FOLLOWING FIELDS WERE UPDATED AS A RESULT: B.5 IT WAS REPORTED THAT THE BD BD ALARIS¿ LVP IV SET HAS SEPARATED AND LEAKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NS LINE BROKE OFF FROM THE BLOOD ADMINISTRATION INFUSION SET. THERE WAS A SPILLAGE OF BLOOD AND NS. POTENTIAL FOR STAFF EXPOSURE TO BLOOD PRODUCT." D1: MEDICAL DEVICE BRAND NAME: BD ALARIS¿ LVP BLD180M 15D SS. D3: MEDICAL DEVICE MANUFACTURER : SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D4: MEDICAL DEVICE CATALOG #: 2477-0007. D4: MEDICAL DEVICE LOT #: 19095578. D4: UNIQUE IDENTIFIER (UDI) #: (B)(4). D4: MEDICAL DEVICE EXPIRATION DATE: 2022 SEP 07. G1: MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G5: PMA/510(K)#: K894842. H4: DEVICE MANUFACTURE DATE: 2019 SEP 07.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF TUBING DEFECTIVE/DAMAGED COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2477-0007 LOT NUMBER 19095578 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 11,463 UNITS IN 1 LOT NUMBER WAS BUILT ON 07SEP2019. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ LVP BLD180M 15D SS HAS SEPARATED AND LEAKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NS LINE BROKE OFF FROM THE BLOOD ADMINISTRATION INFUSION SET. THERE WAS A SPILLAGE OF BLOOD AND NS. POTENTIAL FOR STAFF EXPOSURE TO BLOOD PRODUCT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ LVP BLD180M 15D SS HAS SEPARATED AND LEAKED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NS LINE BROKE OFF FROM THE BLOOD ADMINISTRATION INFUSION SET. THERE WAS A SPILLAGE OF BLOOD AND NS. POTENTIAL FOR STAFF EXPOSURE TO BLOOD PRODUCT."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION CONCLUSION: THE CUSTOMER COMPLAINT OF TUBING DEFECTIVE/DAMAGED COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED AS NO PRODUCT WAS RETURNED. RATIONALE: THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD SMARTSITE¿ NEEDLE-FREE VALVE PORT FILTER SET WAS DAMAGED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "F26 - NO HEALTH CONSEQUENCES OR IMPACTE2403 - NO CLINICAL SIGNS SYMPTOMS OR CONDITIONSA0401 - BREAK HEALTH EFFECT MEDICAL DEVICE PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561825 BD ALARIS¿ LVP BLD180M 15D SS INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2477-0007 19095578 37613203019478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown