BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3211799 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17744
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD893875 AND GD894162 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ONSET OF THIS PERITONITIS EVENT OCCURRED IN (B)(6) 2013. A SAMPLE WAS NOT AVAILABLE FOR ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS FROM AN UNKNOWN CONTAMINATION. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. TREATMENT RENDERED WAS NOT REPORTED. THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310246 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL 1.5% ULTRABAG| DIANEAL 2.5% ULTRABAG