BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2213861 · Received August 17, 2011

    Report

    Report Number
    1423500-2011-10797
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H10H31055, H10K29039, H11B07024, AND H11D12038 WITH NO DEFECTS NOTED DURING THE MANUFACTURE OF THESE LOTS RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). IN (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND WAS TREATED AT HOME. FURTHER TREATMENT INFORMATION, THE CAUSE OF THE PERITONITIS AND WHETHER A PERITONEAL EFFLUENT CULTURE WAS PERFORMED, WERE NOT REPORTED. ALSO, ACTION TAKEN WITH DIANEAL THERAPY AND THE OUTCOME FOR THE EVENT WERE NOT REPORTED. MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT REPORTED. THE NURSE DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other DIANEAL PD4 AMBUFLEX