BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 9836811 · Received March 16, 2020

    Report

    Report Number
    1416980-2020-01430
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 14, 2020
    Report Date
    April 9, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081441
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS ADDED: PMA/510K # CORRECTION: K071222 (PREVIOUSLY NA). THE LOT WAS MANUFACTURED FROM JULY 23, 2019 - JULY 24, 2019. ONE (1) ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND FOUND THE BLADDER HAS BEEN RUPTURED. THE RUPTURED BLADDER WAS MICROSCOPICALLY EXAMINED AND THERE WERE NO SIGNS OF ABNORMALITY THAT MAY HAVE POTENTIALLY CAUSED THE RUPTURE PROBLEM. THE REPORTED CONDITION OF UNSPECIFIED DAMAGE WAS CONFIRMED TO BE A RUPTURED BLADDER. THE CAUSE OF THE RUPTURED BLADDER COULD NOT BE DETERMINED. THE REMAINING DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. 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 TWO (2) SMALL VOLUME INFUSORS WERE OBSERVED TO HAVE UNSPECIFIED DAMAGE. THESE ISSUES WERE OBSERVED DURING SETUP/PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300669 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19G029 00085412081441

    Patients

    Seq Age Sex Outcome Treatment
    1