BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3191403 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16492
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES WERE ADDED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS ALSO SCHEDULED TO HAVE THEIR CATHETER REMOVED ON AND WAS GOING TO BE PLACED ON TEMPORARY HEMODIALYSIS. THE PATIENT PLANNED TO RETURN TO PD THERAPY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF THIS EVENT WAS NOT REPORTED. HOWEVER, THE PATIENT EXPERIENCE PERITONITIS IN (B)(6) 2013. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBER GD894188 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).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY TENDER ABDOMEN, PAIN IN LOWER ABDOMEN, AND CLOUDY PD EFFLUENT. THE PATIENT WAS TREATED WITH IP VANCOMYCIN (DOSE, FREQUENCY NOT REPORTED) AND IP GENTAMYCIN (DOSE, FREQUENCY NOT REPORTED). THE PATIENT RECOVERED FROM THE EVENTS OF PERITONITIS AND DID NOT FEEL GOOD. ON A SEPARATE DATE, THE PATIENT AGAIN EXPERIENCED TENDER ABDOMEN, PAIN IN LOWER ABDOMEN, LOSS OF APPETITE, DID NOT FELL GOOD, AND CLOUDY PD EFFLUENT. THE PATIENT WAS DIAGNOSED WITH RECURRENT PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH IP VANCOMYCIN (DOSE AND FREQUENCY NOT REPORTED) AND IP GENTAMYCIN (DOSE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS RECOVERING FROM ALL THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289959 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL 2.5% AND EXTRANEAL VIAFLEX