BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3092167 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11228
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL SUBMISSION CONTAINED INCORRECT DATE. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON A PROPER ASEPTIC TECHNIQUE. THE PATIENT RECOVERED FROM PERITONITIS. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS: H12H27051, AND H12J01053 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

    THIS IS REPORT 4 OF 4. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT HAD SYMPTOMS OF ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS TREATED WITH ANCEF 1500 MILLIGRAMS INTRAPERITONEAL (IP) DAILY FOR 3 DAYS AND GENTAMYCIN 40 MILLIGRAM IP DAILY. AFTER CULTURES RESULTS WERE NEGATIVE, ANCEF WAS STARTED AS 1 GRAM DAILY IP FOR 5 DAYS. THE PATIENT IS CONSIDERED TO BE RECOVERED FROM THIS EVENT AND THE CAUSE OF PERITONITIS IS UNKNOWN. PD THERAPY WAS ONGOING DURING THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194713 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention AMBUFLEX, EXTRANEAL