BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 2000067 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02393
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD879171 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF FUNGAL PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG, AND EXTRANEAL VIAFLEX THERAPIES, INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THAT ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE IN 2011, DIANEAL AND EXTRANEAL THERAPY WAS WITHDRAWN AND THE PATIENT'S PD CATHETER WAS REMOVED. THE PATIENT HAD NOT RECOVERED FROM THE EVENT. ACCORDING TO THE NURSE, THE EVENT OF FUNGAL PERITONITIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG, AND EXTRANEAL VIAFLEX THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG