BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2922843 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01417
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD893172 AND GD893149 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE CONSUMER. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED. DURING A FOLLOW UP CALL WITH THE NURSE, THE FOLLOWING WAS REPORTED. THE NURSE CLARIFIED THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28166 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX| HOMECHOICE