BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2924036 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01504
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 28, 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 FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS INCIDENT. 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 THE POTENTIALLY ASSOCIATED LOT NUMBER GD893149. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL AND EXTRANEAL THERAPIES WAS NOT REPORTED. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS AND TREATMENT WERE NOT REPORTED. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED. THE CONSUMER DECLINED TO PROVIDE FURTHER INFORMATION. ON CONTACT, THE NURSE DECLINED TO PROVIDE ANY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29433 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other DIANEAL PD4 AMBUFLEX| HOMECHOICE| EXTRANEAL VIAFLEX