BEUDAMED
    FDA Adverse Event Summary report: N

    1423500-2010-03382

    MDR report key: 1832559 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03382
    Date Received
    September 13, 2010
    Product Code
    KDJ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT (10C02H25), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4)AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED.THIS REPORT IS RELATED TO MEDWATCH REPORT 1423500-2010-03380.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER CONTINUES TO DISPLAY THE APPLY SAMPLE MESSAGE WHEN TESTING. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    DURING FOLLOW-UP FOR AN UNRELATED HOMECHOICE ALARM, IT WAS REPORTED THAT THE PATIENT HAD PERITONITIS. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE PATIENT'S PERITONEAL DIALYSIS (PD) NURSE ON (B)(6)2010: ON AN UNSPECIFIED DATE, THE PATIENT BEGAN PD THERAPY WITH REGULAR CAL (PD2) AMBUFLEX. THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6)2010 AND WAS HOSPITALIZED FROM (B)(6)2010 THROUGH (B)(6)2010. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THIS PERITONITIS. A CELL COUNT WAS PERFORMED ON THE PATIENT'S EFFLUENT ON (B)(6)2010 SHOWING 18,075 LEUCOCYTES, 3% LYMPHOCYTES, AND 2% MONOCYTES. A GRAM STAIN WAS ALSO PERFORMED SHOWING NO GROWTH. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAS RECOVERED. THE NURSE INDICATED THE PERITONITIS WAS DUE TO A BREAK IN ASEPTIC TECHNIQUE AND NOT DUE TO ANY PROBLEMS WITH ANY OF THE PATIENT?S BAXTER PD SOLUTIONS OR DISPOSABLES. DURING ADDITIONAL FOLLOW-UP ON (B)(6)2010, THE NURSE INDICATED THE PATIENT'S TRANSFER SET WAS REPLACED WHEN THE PERITONITIS WAS DIAGNOSED. THE NURSE DID NOT KNOW THE PRODUCT CODE OR LOT NUMBER BUT INDICATED, IT WAS A SHORT MINICAP TRANSFER SET WITH TWIST CLAMP. THE NURSE INDICATED THERE WAS NO DEFECT OR MALFUNCTION OF ANY OF THE PATIENT'S PD PRODUCTS ASSOCIATED WITH THIS PERITONITIS EPISODE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 REGULAR CAL (PD2) AMBUFLEX