BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2973535 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04417
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORTED ISSUE IS NOT CONFIRMED AND THE CAUSE WAS UNDETERMINED BECAUSE THERE WAS NO SAMPLE RETURNED TO BAXTER FOR EVALUATION. A SAMPLE WAS REQUESTED, BUT WAS NOT AVAILABLE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES OR DEVIATIONS NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED FOUR DAYS AFTER THE TRANSFER SET WAS CHANGED AND TIGHTENED BY THE NURSE, THE PATIENT WOKE UP IN MIDDLE OF NIGHT DURING AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY DUE TO A FLUID LEAK FROM CATHETER AND FOUND THAT THE MINI-CAP TRANSFER SET HAD DISCONNECTED FROM THE TITANIUM ADAPTER (ADDRESSED IN (B)(4)). THE EXACT CAUSE OF THE DISCONNECTION WAS UNKNOWN, BUT SUSPECTED TO BE RELATED TO THE PATIENT LOOSENING THE CONNECTION WHILE CHANGING SOLUTION BAGS. IT WAS UNKNOWN HOW THE TRANSFER SET WAS BEING STORED WHEN NOT IN USE. THERE WAS NO DAMAGE NOTED TO THE THREADS OF THE ADAPTER. ON THE SAME DAY OF THE DISCONNECTION, THE PATIENT WENT TO THE HOSPITAL DUE TO THE DISCONNECTION. THE PATIENT WAS ADMITTED ON THE SAME DAY AND DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. APD THERAPY WAS TEMPORARILY DISCONTINUED. DURING THE HOSPITALIZATION, THE TRANSFER SET WAS REPLACED AND APD THERAPY WAS RESTARTED. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT, BUT REMAINED HOSPITALIZED DUE TO FEELING UNWELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78058 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12F18054

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R HOMECHOICE| TITANIUM ADAPTER| EXTRANEAL| DIANEAL PD4 AMBUFLEX 2.5%