BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE AMBER INFUSION SET

    MDR report key: 10311940 · Received July 22, 2020

    Report

    Report Number
    9616066-2020-02276
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    June 26, 2020
    Report Date
    June 30, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203019200
    PMA / PMN Number
    K931173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF THE MODEL 2203-0500 INFUSION SET BREAKING IN TWO WHILE USING IT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2203-0500 BECAUSE AN INVALID LOT NUMBER WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF ALARIS PUMP MODULE AMBER INFUSION SETS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THE PRODUCT ¿BROKE INTO 2 PIECES WHILE FLUID WAS RUNNING THROUGH IT¿. DOE IS (B)(6) 2020, AND WAS STATED THE INCIDENT HAPPENED DURING USE. CUSTOMER HAD NO FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF (10)19106851 WAS PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF ALARIS PUMP MODULE AMBER INFUSION SETS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THE PRODUCT ¿BROKE INTO 2 PIECES WHILE FLUID WAS RUNNING THROUGH IT¿. DOE IS (B)(6) 2020, AND WAS STATED THE INCIDENT HAPPENED DURING USE. CUSTOMER HAD NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775754 ALARIS PUMP MODULE AMBER INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN 07613203019200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200626| 20200626| 20200626