BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3874493 · Received June 16, 2014

    Report

    Report Number
    1416980-2014-19123
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    January 27, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13G08029 AND H13J04064 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. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT AND TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, ROUTE AND FREQUENCY NOT REPORTED). DURING HOSPITALIZATION THE PD CATHETER WAS REMOVED AND PATIENT WAS PLACED ON HEMODIALYSIS. THE PATIENT RECEIVED ADDITIONAL TREATMENT WITH AN UNSPECIFIED ANTIBIOTIC VIA HEMODIALYSIS FOR THE EVENT. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL AND REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. HEMODIALYSIS THERAPY WAS REPORTED TO BE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352282 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| HOMECHOICE| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| MINICAP