BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10562640 · Received September 21, 2020

    Report

    Report Number
    1416980-2020-05863
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Report Date
    October 27, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412579399
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO F10/H6: DEVICE CODES (REPLACE 2199 WITH 2645). B5: PER UPDATED INFORMATION FROM THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT. REPLACE "THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT." WITH "THERE WAS NO PATIENT INVOLVEMENT." H4: THE LOT WAS MANUFACTURED FROM JULY 31, 2019 TO AUGUST 1, 2019. THE DEVICE WAS RECEIVED FOR EVALUATION CONTAINING APPROXIMATELY 240ML OF FLUID IN THE BLADDER. VISUAL INSPECTION REVEALED A LEAK/BACKFLOW AT THE FILL PORT  WHEN THE FILL PORT CAP WAS REMOVED. THE LEAK/BACKFLOW WAS DUE TO A PARTICLE LODGED UNDER THE DEVICE CHECKBAND. THE PARTICLE WAS SUBSEQUENTLY IDENTIFIED TO BE ACRYLIC MATERIAL VIA FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY TEST. ACRYLIC IS THE MATERIAL OF THE DEVICE STRESS MEMBER LOCATED INSIDE THE BLADDER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THE MOST PROBABLE ROOT CAUSE OF ACRYLIC FRAGMENT BECOMING LODGED UNDER THE CHECKBAND IS SUPPLIER RELATED. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CE INFUSOR LV (LARGE VOLUME) LEAKED DURING FILLING. THE DEVICE WAS FILLED WITH FLUOROURACIL. 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
    1022910 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19G058 00085412579399

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL| FLUOROURACIL