BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET

    MDR report key: 14515230 · Received May 26, 2022

    Report

    Report Number
    2243072-2022-00736
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    October 7, 2021
    Report Date
    June 1, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203015806
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A CRACK FORMED IN THE BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET AND LEAKED OUT TAXOL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED VOICE MAIL ABOUT A LEAKING SET USING TAXOL. THE SET WAS A 10010455. A PRECIPITATE WAS FORMING IN THE LINE AND THE TUBING CRACKED AND BEGAN TO LEAK NEAR THE BAG ATTACHMENT." D.1. MEDICAL DEVICE BRAND NAME: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET D.1. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET D.2. MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D.2. MEDICAL DEVICE TYPE: FPA D.4. MEDICAL DEVICE CATALOG #: 10010454. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA/510(K)#: K944320 H.6 IMDRF ANNEX B CODE(S): B17 H.6 IMDRF ANNEX C CODE(S): C20 H.6 IMDRF ANNEX D CODE(S): D15 H.6 IMDRF ANNEX G CODE(S): G04134 H.6 INVESTIGATION SUMMARY: A COMPLAINT OF TUBING CRACKING AND LEAKING WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. 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. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACK FORMED IN THE UNSPECIFIED BD¿ INFUSION SET TUBING AND LEAKED OUT TAXOL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED VOICE MAIL ABOUT A LEAKING SET USING TAXOL. THE SET WAS A 10010455. A PRECIPITATE WAS FORMING IN THE LINE AND THE TUBING CRACKED AND BEGAN TO LEAK NEAR THE BAG ATTACHMENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACK FORMED IN THE BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET AND LEAKED OUT TAXOL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED VOICE MAIL ABOUT A LEAKING SET USING TAXOL. THE SET WAS A 10010455. A PRECIPITATE WAS FORMING IN THE LINE AND THE TUBING CRACKED AND BEGAN TO LEAK NEAR THE BAG ATTACHMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768990 BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 07613203015806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown