BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2232059 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11606
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS IS NOT CONFIRMED BECAUSE NO SAMPLES WAS RETURNED TO BAXTER, REVIEWS OF MANUFACTURING RECORDS REVEALED NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE, AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. A LABELING REVIEW WAS NOT REQUIRED SINCE THERE IS NO SUSPECTED USE ERROR OR PROBLEM ASSOCIATED WITH LABEL CONTENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV). THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF EXIT SITE ABSCESS RESULTING IN (B)(6) INFECTION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL ULTRABAG THERAPIES. ON AN UNREPORTED DATE IN 2011, THE PATIENT HAD EXIT SITE ABSCESS RESULTING IN (B)(6) INFECTION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND THE OUTCOME FOR THE EXIT SITE ABSCESS RESULTING IN (B)(6) INFECTION WAS NOT REPORTED. ON AN UNKNOWN DATE, DIANEAL THERAPIES WERE WITHDRAWN. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE CONSUMER STATED THE PERITONITIS WAS DUE TO THE EXIT SITE ABSCESS RESULTING IN (B)(6) INFECTION. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EXIT SITE ABSCESS RESULTING IN (B)(6) INFECTION. THE NURSE STATED THE PERITONITIS WITH CULTURE POSITIVE FOR ENTEROCOCCUS WAS NOT RELATED TO DIANEAL AND EXTRANEAL THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization DIANEAL PD4 AMBUFLEX| DIANEAL ULTRABAG