BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3181354 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16094
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACTUAL DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS KNOWN THAT THE EVENT DID OCCUR SOMETIME LAST WEEK. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H12D16046 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE PATIENT USED AN ALCOHOL BASED SOLVENT TO CLEAN THE TRANSFER SET WHICH IS A USE ERROR AGAINST CURRENT LABELING. THE INSTRUCTIONS FOR USE OF THE TRANSFER SET INSTRUCT THE CUSTOMER NOT APPLY HYDROGEN PEROXIDE, ALCOHOL, OR ANTISEPTIC AGENTS CONTAINING ALCOHOL TO THE CONNECTORS. THE CAUSE OF THE LEAK COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINICAP TRANSFER SET HAD A BROKEN INTERNAL CLAMP AND HAD CRACKS ON THE BODY, CAUSING A LEAK OF PERITONEAL DIALYSIS SOLUTION. BETADINE WAS USED BY THE CLINIC WHEN THE TRANSFER SET WAS INITIALLY PUT INTO THE HOME PATIENT (HP). HOWEVER, THE HP WAS USING 70% ALCOHOL BASED SOLUTION FOR CLEANING THE TRANSFER SET. AS A RESULT, THE MINICAP TRANSFER SET HAD TO BE REPLACED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282050 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12D16046

    Patients

    Seq Age Sex Outcome Treatment
    1 PERITONEAL DIALYSIS SOLUTION| BETADINE| AHDEZ| HOMECHOICE AUTOMATED PD SET WITH CASSETTE