BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 4200007 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37279
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON LOT NUMBER 14F19G73 AND THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE ACCUSOL DIALYSATE CONCENTRATE BAG WAS IDENTIFIED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, THE LOT NUMBER IS KNOWN AND A BATCH RECORD REVIEW IS ANTICIPATED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HEALTHCARE PROFESSIONAL WHO EXPERIENCED A LEAK AT THE SEAL OF AN ACCUSOL DIALYSATE CONCENTRATE BAG USED FOR HEMODIALYSIS. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THE REPORTED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678153 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 14F19G73

    Patients

    Seq Age Sex Outcome Treatment
    1