BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 2251592 · Received September 16, 2011

    Report

    Report Number
    1423500-2011-12324
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 30, 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). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD885301 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE USE ERROR WHICH RESULTED IN THE PERITONITIS WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH 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 4 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 IN 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 AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS REPORTED AS PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. TREATMENT INFORMATION WAS NOT PROVIDED. ON (B)(6) 2011 THE PATIENT WAS DISCHARGED AND WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME FOR THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. DIANEAL PD4 AMBUFLEX THERAPY WAS ONGOING. AN OPINION OF CAUSALITY WAS NOT PROVIDED. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization DIANEAL PD4 AMBUFLEX