BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3994369 · Received August 8, 2014

    Report

    Report Number
    1416980-2014-25736
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD896704 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 PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY FLUID EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, DURING THE HOSPITALIZATION, THE PATIENT RECEIVED AN UNSPECIFIED ANTIBIOTIC THERAPY (FURTHER DETAIL NOT REPORTED) AS A TREATMENT FOR PERITONITIS. WHILE THE PATIENT WAS HOSPITALIZED, THE PATIENT PERFORMED THERAPY WITH MANUAL SUPPLIES. ONE WEEK AFTER THE ONSET OF PERITONITIS, THE PATIENT STARTED TO PERFORM THERAPY WITH SOLUTION BAGS WITH UNSPECIFIED ANTIBIOTICS IN THEM. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS. ON AN UNREPORTED DATE, THE DIANEAL THERAPY WAS WITHDRAWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472633 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R HOMECHOICE AUTOMATED PD SET WITH CASSETTE,| HOMECHOICE, MINICAP TRANSFER SET| 2.5% DIANEAL PD4 AMBUFLEX, INSULIN,