BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 6798248 · Received August 16, 2017

    Report

    Report Number
    1416980-2017-06666
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Report Date
    February 18, 2022
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5: THE AFFECTED PRODUCT WAS A ¿LARGE VOLUME INFUSOR¿, PREVIOUSLY SUBMITTED AS ¿SINGLE-DAY INFUSOR¿. D4: THE CORRECT CATALOGUE # WAS ¿2C1009K¿, PREVIOUSLY SUBMITTED AS ¿2C1071KJP¿. D4: THE UDI #: IS ¿(B)(4)¿, PREVIOUSLY SUBMITTED AS ¿BLANK¿. G4: 510K #: ¿K062457" WILL BE REMOVED AND REPLACED WITH ¿NA¿ H10: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED SOMETIME IN (B)(6) 2017. MANUFACTURING DATE: OCTOBER 14, 2016 ¿ OCTOBER 18, 2016. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK FROM THE TIP OF THE TUBING OF A SINGLE-DAY INFUSOR. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578394 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE NA 16K025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown