BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2864676 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06872
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 18, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 IS NOT AVAILABLE. AN INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. 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. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBERS H12B29043, H12C30049, H12D30047, H12E29053, H12F28087, H12G09010, H12G27079, H12H31095, H12G27079, AND H12H31095 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION:THIS CONDITION WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED, AS NO SAMPLE WAS RETURNED TO BAXTER. THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION FOR THIS INITIAL PERITONITIS CASE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) FOR AN UNRELATED ISSUE. THE HOME PATIENT (HP) STATED THEY HAD PERITONITIS. FOLLOW-UP WAS PERFORMED ON (B)(6) 2012 WITH THE HP WHO STATED SHE ACQUIRED PERITONITIS DUE TO CONSTIPATION. THE HP WAS HOSPITALIZED FOR THE PERITONITIS FROM (B)(6) 2012. THE HP STATED THAT SHE HAS BEEN ON AN ANTIBIOTIC FOR THE LAST TWO WEEKS (EXACT START DATE UNKNOWN) AND SHE HAS FOUR DAYS LEFT. SHE DOESN'T KNOW WHAT THE ANTIBIOTIC IS BUT STATED THAT IT'S YELLOW AND SHE ADMINISTERS IT INTRAPERITONEALLY (IP). THE HP STATED THEY WERE RECOVERING FROM THE PERITONITIS. THE HP ALSO STATED THAT THE PERITONITIS WAS NOT RELATED TO BAXTER SOLUTIONS, DEVICES OR DISPOSABLE PRODUCTS. AN ATTEMPT TO OBTAIN FURTHER INFORMATION CONCERNING THIS EVENT WAS MADE WITH THE PERITONEAL DIALYSIS (PD) CLINIC UNIT MANAGER. HOWEVER, THE PD CLINIC UNIT MANAGER REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION ON THIS EVENT.

    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 52 YR Hospitalization| R (B)(4) DIANEAL LOW CA 1.5% DEX 6L/6L| (B)(4) DIANEAL LOW CA 4.25% 6L/6L| 78P LOW CA 2.5% 2.5L/3L UB DIANEAL| (B)(4) DIANEAL LOW CAL 2.5% DEX 6L/6L| 68P LOW CA 1.5% 2.5L/3L UB DIANEAL| (B)(4) LOW CA 4.25% 2.5/3L UB DIANEAL