BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3951246 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23740
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DIETICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER ¿ THE PATIENT WAS PRESCRIBED TWO PRODUCT CODES FOR THIS PRODUCT. IT IS UNKNOWN WHICH PRODUCT CODE WAS IN USE AT THE TIME OF THE EVENT. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14C11054, H14A15026, AND H13K04070. THERE WERE NO ISSUES DETECTED DURING MANUFACTURING PROCESSES. 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. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY SYMPTOMS OF LOW BLOOD SUGAR AND DIZZINESS. THE CAUSE OF PERITONITIS IS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. SEVEN DAYS LATER, THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) VANCOMYCIN AND (IV) GENTAMICIN (DOSES AND FREQUENCIES NOT REPORTED) FOR PERITONITIS. THE NEXT DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, BOTH TREATMENTS WERE ONGOING. DIANEAL THERAPIES WERE DISCONTINUED, THE PATIENT'S PD CATHETER WAS REMOVED, AND HEMODIALYSIS THERAPY WAS STARTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428041 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R DIANEAL 2.5% SINGLEBAG, DIANEAL 2.5% ULTRABAG| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE, MINICAP, EXTENSION SET, FLEXICAP