BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1960148 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00549
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    September 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW COULD NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 4 ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER 10E17H25 WITH NO DEFECTS NOTED. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE SECOND OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    BAXTER GLOBAL PHARMACOVIGILANCE (GPV) REPORTED A PATIENT RECEIVING PERITONEAL DIALYSIS(PD) THERAPY DEVELOPED PERITONITIS IN (B)(6) 2010. ON (B)(6) 2010, THE PATIENT REPORTEDLY WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNSPECIFIED DATE IN 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND RESULTS WERE (B)(6). ON (B)(6) 2010, ANOTHER FACILITY NURSE INDICATED: THE PERITONITIS IDENTIFIED AS BACTERIAL PERITONITIS WITH CULTURE (B)(6). ON AN UNREPORTED DATE, WHILE TRAVELING, THE PATIENT REPORTEDLY RECEIVED A SHIPMENT OF SOLUTION WHICH CONTAINED 6 CLOUDY BAGS OF DIANEAL PD4 AMBUFLEX . THE PATIENT REPORTEDLY PERFORMED DIALYSIS USING THE CLOUDY BAGS RESULTING IN BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. ON (B)(6) 2010, A PERITONEAL EFFLUENT ANALYSIS, CULTURE AND GRAM STAIN WERE PERFORMED PRIOR TO THE INITIATION OF ANTIBIOTIC THERAPY. THE RESULTS OF THE ANALYSIS AND GRAM STAIN WERE UNKNOWN. VANCOMYCIN 1 GRAM INTRAPERITONEAL (IP) (FREQUENCY NOT REPORTED) WAS INITIATED. THE NURSE WAS UNSURE IF AN EXIT SITE INFECTION WAS ASSOCIATED WITH THIS PERITONITIS. A SECOND PERITONEAL EFFLUENT CULTURE WAS PERFORMED ON (B)(6) 2010 AND RESULTS INDICATED NO GROWTH WAS SEEN. THE PERITONITIS WAS CONSIDERED TO BE RESOLVED. THE PATIENT HAD BEEN ON A TOTAL OF 4 WEEKS OF UNSPECIFIED ANTIBIOTIC THERAPY. THE NURSE BELIEVED THAT THE EVENT OF BACTERIAL PERITONITIS WAS RELATED TO PD THERAPY. THE MD REPORTEDLY ATTRIBUTED THE PERITONITIS TO THE CLOUDY DIANEAL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAP DISCONNECT CAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention HOMECHOICE CYCLER| 1.5%, 2.5% AND 4.25% 2L/2L. 1.5%, 2.5% AND 4.25%