BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 12061508 · Received June 24, 2021

    Report

    Report Number
    9616066-2021-51392
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 10, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MAXPLUS CLR POSITIVE DISPLACEMENT CONN EXPERIENCED DAMAGE AND LEAKAGE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THIS IS A MAX PLUS ISSUE THAT OCCURRED AGAIN YESTERDAY IN ICU THE MAX PLUS WAS CONNECTED TO A 3 WAY TAP- THE CRACK WAS LOCATED NEAR THE CONNECTION POINT TO THE BD 3 WAY TAP HAS THERE BEEN ANY FEEDBACK BY BD QUALITY REGARDING THIS ISSUE REPORTED IN APRIL? FROM CLINICIAN: DOING A QUICK LOCAL INVESTIGATION SHOWED THE DEFECT QUITE CLEARLY. IT'S DIFFICULT TO CAPTURE ON CAMERA OWING TO ITS SMALL SIZE AND CLEAR PLASTIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958274 MAXPLUS CLR POSITIVE DISPLACEMENT CONN INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1