BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2221902 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11186
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 5, 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 REPORT FOR PERITONITIS CANNOT BE CONFIRMED AS NO SAMPLES ARE AVAILABLE. A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER GD885301 WITH NO ISSUES NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    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 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 CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THAT SAME DAY. FOR TREATMENT OF THE EVENT, THE PATIENT RECEIVED UNSPECIFIED ANTIBIOTICS, THE PD CATHETER WAS REMOVED, AND THE PATIENT WAS PLACED ON BACK-UP HEMODIALYSIS (HD). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE NURSE STATED A POSSIBLE CAUSE OF THE EVENT COULD HAVE BEEN A BREAK IN ASEPTIC TECHNIQUE, BUT THAT COULD NOT BE PINPOINTED. THE NURSE STATED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. THERAPY WITH DIANEAL PD4 AMBUFLEX WAS ONGOING.

    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 47 YR Hospitalization| R DIANEAL PD4 AMBUFLEX