BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3120513 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12911
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 26, 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). . A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBER GD893743 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. THIS IS THE SAME PATIENT AS (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). THERAPY WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE NOT REPORTED) FOR THE PERITONITIS. THE PD CATHETER WAS REMOVED. THE PATIENT WAS RECOVERING FROM THE EVENTS AT THE TIME OF THIS REPORT. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221696 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R DIANEAL PD4 ULTRABAG| HOMECHOICE, DIANEAL PD4 AMBUFLEX