BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 17009886 · Received May 26, 2023

    Report

    Report Number
    1416980-2023-02568
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    April 26, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081502
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6 AND H10. H10: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION CONTAINING FLUID IN THE BLADDER. A VISUAL INSPECTION WAS DONE WHICH OBSERVED FLUID INSIDE THE HOUSING WHICH SUGGESTED A LEAK. A LEAK TEST WAS PERFORMED WHICH REVEALED A SLOW LEAK COMING OUT AT ONE SIDE OF THE BLADDER CRIMP. THE REPORTED CONDITION WAS VERIFIED DURING THE EVALUATION OF THE ACTUAL SAMPLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: G3: DATE RECEIVED BY MFR IN FOLLOW-UP MDR #1 IS BEING CORRECTED TO 11/28/2023.

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A VIDEO OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE VIDEO WAS REVIEWED AND SHOWED EVIDENCE OF A LEAK AT THE BLADDER CRIMP INSIDE THE DEVICE BOTTLE (HOUSING). THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF BLADDER CRIMP LEAK WAS RELATED TO MANUFACTURING. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LARGE VOLUME MULTIRATE INFUSOR LEAKED FROM THE BALLOON. THIS OCCURRED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849460 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 22K005 00085412081502

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown