BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3852036 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-18060
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13H08043, H13I25011, H13K14046, AND H13J04064 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. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON AN UNSPECIFIED DATE IN (B)(6) 2014. THE PATIENT WAS PRESCRIBED TWO PRODUCT CODES FOR THIS PRODUCT. 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, MANUFACTURING SITE, AND 510K NUMBER WHICH HAVE BEEN PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN AND TREATMENT FOR THE EVENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED AFTER A WEEK IN THE HOSPITAL AND WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329241 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD4 AMBUFLEX, MINICAP| HOMECHOICE, FLEXICAP, CASSETTE