BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3230266 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18690
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE WAS DISCARDED; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBERS H12H31095, H12L13070 AND H13D08067 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. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBER H12J11037 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. AN EXCEPTION WAS NOTED FOR THE BATCH BUT DOES NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): ON (B)(4) 2013, FOLLOW UP INFORMATION WAS RECEIVED RELATED TO THIS EVENT. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERING FROM THE PERITONITIS. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN AND TREATMENT INFORMATION WAS NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329852 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization HOMECHOICE AUTOMATED PD SET WITH CASSETTE| MINICAP, FLEXICAP| HOMECHOICE, DIANEAL, EXTRANEAL VIAFLEX,