BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER

    MDR report key: 2243412 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12066
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11C03013 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE USER ERROR WHICH RESULTED IN THE PERITONITIS WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USER 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 2OF 2 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 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 AN UNREPORTED DATE, THE PATIENT DID NOT WEAR A MASK, AND THIS BREAK IN ASEPTIC TECHNIQUE RESULTED IN PERITONITIS ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED SEIZURE ACTIVITY. TREATMENT FOR THE EVENTS AND A HOSPITAL DISCHARGE DATE WERE NOT REPORTED. THE OUTCOME OF THE EVENTS DID NOT WEAR A MASK AND SEIZURE ACTIVITY WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS. THERAPY WITH DIANEAL WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT DID NOT WEAR A MASK. HOWEVER, SHE STATED THAT THE EVENTS PERITONITIS AND SEIZURE ACTIVITY WERE NOT RELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization DIANEAL PD4 AMBUFLEX