BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3943426 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23184
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13K26065, H14A09029, H14A07064, AND H14B28035 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN, CLOUDY BAG AND A FEVER. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THREE DAYS AFTER THE ONSET, THE PATIENT BEGAN TREATMENT WITH 1 GRAM CEFAZOLIN IP DAILY, AND 500MG CIPRO TWICE A DAY ORALLY FOR PERITONITIS. THREE WEEKS LATER, TREATMENT WITH CEFAZOLIN AND CIPRO WAS DISCONTINUED. IN THE MONTH AFTER THE ONSET OF PERITONITIS, THE PATIENT WAS RECOVERED. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422967 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention DIANEAL PD4 1.5% AND 2.5% AMBUFLEX| HOMECHOICE| HOMECHOICE AUTOMATED PD SET WITH CASSETTE