BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2230073 · Received August 31, 2011

    Report

    Report Number
    1423500-2011-11499
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER: GD879171 WITH NO DEFECTS NOTED DURING THE MANUFACTURE OF THESE LOTS RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. 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 REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT 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 THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. TREATMENT WAS NOT REPORTED. THE OUTCOME OF THE EVENT AND THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT REPORTED. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION.

    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 27 YR Other DIANEAL PD4 AMBUFLEX