BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2233329 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11635
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 17, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS IS NOT CONFIRMED BECAUSE THE SAMPLE WAS NOT RETURNED TO BAXTER. NO DEFECTS OR DEVIATIONS WERE FOUND DURING THE BATCH REVIEW THAT COULD BE ASSOCIATED WITH THE REPORTED PROBLEM. A ROOT CAUSE WAS NOT IDENTIFIED. A LABELING REVIEW WAS NOT REQUIRED SINCE THERE IS NO SUSPECTED USE ERROR OR PROBLEM ASSOCIATED WITH LABEL CONTENT. 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.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV). THIS IS A SPONTANEOUS NURSE REPORT FROM THE USA OF KLEBSIELLA AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. DURING A CALL TO BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD GALLBLADDER SURGERY FOR AN UNREPORTED INDICATION. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED KLEBSIELLA THAT MAY HAVE RESULTED FROM THE GALLBLADDER SURGERY. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT HAD RECOVERED FROM THE KLEBSIELLA. THE NURSE REPORTED THAT THE KLEBSIELLA WAS THE CAUSE OF PERITONITIS. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT RECOVERED AND WAS STILL IN THE HOSPITAL. IT WAS PLANNED TO HAVE THE PATIENT'S PD CATHETER REMOVED. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE NURSE REPORTED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA UNKNOWN WAS UNRELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF KLEBSIELLA.

    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 70 YR Hospitalization DIANEAL PD4 AMBUFLEX