BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3945002 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23361
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER GD896704 WAS PERFORMED 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 AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING FOLLOW UP THAT THE PATIENT HAD RECOVERED FROM THE PERITONITIS. PATIENT OUTCOME WAS PREVIOUSLY REPORTED AS RECOVERING. ON AN UNREPORTED DATE, PD CATHETER WAS REMOVED DUE TO PERITONITIS. 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 BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THAT THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT AND ABDOMINAL PAIN. ON AN UNREPORTED DATE THE PATIENT WAS TREATED IN THE EMERGENCY ROOM WITH CUBICIN (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) GENTAMYCIN (DOSE AND FREQUENCY NOT REPORTED) FOR THE EVENT. AT THE TIME OF THIS REPORT; THE PATIENT WAS RECOVERING FROM THE EVENT AND HAD BEEN RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS REPORTED TO BE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422056 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R HOMECHOICE, MINICAPTRANSFER SET| DIANEAL PD4 2.5% AND 4.25% AMBUFLEX| CASSETTE, EXTENSION SET