BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 2251025 · Received September 16, 2011

    Report

    Report Number
    1423500-2011-12317
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD886127, GD886028 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USER ERROR WAS IDENTIFIED. 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 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED AND AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. ON AN UNREPORTED DATE IN 2011, THE PATIENT'S PD CATHETER WAS PULLED AND DIANEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN FOR UNREPORTED REASONS. THE NURSE STATED THE EVENT WAS NOT RELATED TO DIANEAL OR EXTRANEAL THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX