BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3170026 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15354
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBER GD894287 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 FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): DIANEAL THERAPIES WERE ONGOING. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BLOOD IN THE BAG. THE PATIENT WAS HOSPITALIZED FOR BLOOD IN THE BAG. ON THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH PERITONITIS IN THE HOSPITAL. ON AN UNKNOWN DATE, THE PATIENT ALSO EXPERIENCED C. DIFFICILE. THE CAUSE AND TREATMENT FOR BLOOD IN THE BAG, PERITONITIS AND C. DIFFICILE WAS UNKNOWN. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2. THIS IS A REPORT PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPIES WAS NOT REPORTED. THE PATIENT HAD AN INFECTION AND BLEEDING THAT TURNED INTO PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT HAD NOT YET RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271561 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization HOMECHOICE, DIANEAL PD4 AMBUFLEX| DIANEAL ULTRABAG 2.5%, DIANEAL ULTRABAG 4.25%