BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 7334658 · Received March 13, 2018

    Report

    Report Number
    1416980-2018-01311
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Report Date
    April 19, 2018
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED 18 APR 2017 ¿ 20 APR 2017. THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. DURING VISUAL INSPECTION OF THE PROVIDED PHOTO, A RUPTURE WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED; HOWEVER, THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADDER OF A SMALL VOLUME INFUSOR RUPTURED DURING FILLING OF AN UNSPECIFIED DRUG. THE FILL VOLUME WAS 40 ML. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176621 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE NA 17D022

    Patients

    Seq Age Sex Outcome Treatment
    1