BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3151070 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14562
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFUSOR WAS BEING USED TO DELIVER 2172 MG ? TV 92 ML FLUOROURACIL (5-FU) WHEN THE LEAK OCCURRED. THE PHARMACY PREPARED ANOTHER DOSE (SAME) WHICH WAS DELIVERED TO THE PATIENT (PT). AFTER THE TREATMENT THE PT WAS DISCONNECTED AND DISCHARGED HOME. THE PT RECEIVED THE ENTIRE DOSE. THE PT WAS BEING TREATED FOR RECTAL CANCER. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR LOT NUMBER 12N041 WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE DEVICE WAS NOT RETURNED. THEREFORE, NO DEVICE ANALYSIS CAN BE PERFORMED AND NO CAUSE WAS DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INFUSOR LEAKED. THE INFUSOR, WITH CHEMOTHERAPY DRUG 5FU, WAS PREPARED BY THE PHARMACY AND THEN IT WAS SENT TO THE FLOOR AND CONNECTED TO A NON-BAXTER LUER. THE NURSES CONNECTED THE LUER TO A NON-BAXTER MINI SET THAT WAS CONNECTED TO THE PATIENT. ABOUT ONE HOUR AFTER THE INFUSION WAS STARTED, BLOOD WAS OBSERVED TO HAVE BACK FLOWED FROM THE PATIENT UP THE IV LINE TO THE NON-BAXTER LUER. AT THIS TIME THE PUMP WAS NOTED TO STILL BE INFUSING. AN UNSPECIFIED AMOUNT OF THE CHEMOTHERAPY DRUG AND BLOOD LEAKED ONTO 2 LAYERS OF THE PATIENT?S GARMENTS. THE PATIENT'S SKIN WAS NOT EXPOSED TO THE CHEMOTHERAPY. THE EXACT AMOUNT OF BLOOD LOSS IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251594 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12N041

    Patients

    Seq Age Sex Outcome Treatment
    1 BARD MINILOC INFUSION SET, 5-FU| BRAUN CARESITE LEUR ACCESS