BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3923541 · Received July 9, 2014

    Report

    Report Number
    1416980-2014-21949
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS PRESCRIBED TWO PRODUCT CODES FOR A MINICAP TRANSFER SET. THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT USED BY THE PATIENT IS UNKNOWN; HOWEVER, THE TWO PRODUCT CODES SHARE A COMMON BRAND NAME AND 510K NUMBER WHICH HAVE BEEN PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11C31030 AND H11D12038 WITH NO ISSUES NOTED THAT COULD BE RELATED TO THE REPORTED EVENT OF PERITONITIS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE CAUSE IS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT INFORMATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399588 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HOMECHOICE| DIANEAL| MINICAP| HOMECHOICE AUTOMATED PD SET WITH CASSETTE