BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3964482 · Received July 29, 2014

    Report

    Report Number
    1416980-2014-24553
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS CMPLNT-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13K06034, H14A13039 AND H14A15026 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS UNKNOWN. ONE DAY PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED FOR THE PERITONITIS WITH GENTAMICIN INTRAVENOUSLY (IV) (60MG EVERY 48HRS). ON AN UNKNOWN DATE, DIANEAL AMBUFLEX THERAPY WAS DISCONTINUED FOR AN UNKNOWN REASON. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS ONGOING, THE PATIENT WAS STILL HOSPITALIZED FOR THE EVENT, AND THE PATIENT¿S CONDITION WAS IMPROVING. THE PATIENT WAS NOT RE-TRAINED IN ASEPTIC PROCEDURES FOR PERFORMING PD THERAPY. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440861 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R DIANEAL PD4 2.5% ULTRABAG, MINICAP| DIANEAL PD4 2.5% AMBUFLEX, HOMECHOICE