BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3251084 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19956
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    January 22, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE AND LOT NUMBER OF THIS PRODUCT ARE UNKNOWN; HOWEVER, THE BRAND NAME AND 510(K) NUMBER OF THE POTENTIAL PRODUCT CODES AND LOTS RECEIVED BY THE CLINIC ARE THE SAME; THEREFORE, THEY WERE PROVIDED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12D27068 AND H12B29043 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS WHILE IN THE HOSPITAL FOR SEVERE BACK PAIN. THE NURSE REPORTED THE CAUSE OF THE PERITONITIS WAS DIARRHEA WHICH HAD CROSSED OVER THE PERITONEAL MEMBRANE. TREATMENT FOR THE PERITONITIS INCLUDED ZYBOX, ORAL (DOSE AND FREQUENCY NOT REPORTED). ON AN UNREPORTED DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THE INITIAL REPORT, THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS EVENT. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352240 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention MINICAP| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL PD4, 2.5% AMBUFLEX, LOW CALCIUM| DIANEAL PD4, 4.25% AMBUFLEX, LOW CALCIUM