BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2934167 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02243
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 9, 2013
    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). THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS IS REPORT 2 OF 4 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER GD893297. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    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 CAREGIVER, IN THE USA. THIS REPORT IS OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE TREATMENT FOR THE EVENT INCLUDED VANCOMYCIN INTRAPERITONEALLY EVERY 4 DAYS, ADMINISTERED IN THE PD CLINIC. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40436 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R DIANEAL PD4 2.5% AMBUFLEX| HOMECHOICE