BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3802958 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15008
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13I04032, H13J02019, H13K06034, H13K26065 AND H13L05034 WAS PERFORMED 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 DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED PERITONITIS ON AN UNSPECIFIED DATE IN (B)(6)2014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS UNKNOWN IF THE PATIENT REQUIRED HOSPITALIZATION. THE PATIENT WAS TREATED WITH CEFAZOLIN FOR 18 DAYS (DOSE, ROUTE AND FREQUENCY NOT REPORTED), CEFTAZIDIME FOR A DAY (DOSE, ROUTE AND FREQUENCY NOT REPORTED), AND VANCOMYCIN (EVERY FIVE DAYS FOR TEN DAYS, DOSE AND ROUTE NOT REPORTED) FOR THE PERITONITIS. THE PATIENT¿S CATHETER WAS LATER REMOVED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280491 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG| HOMECHOICE, MINICAP, EXTENSION SET, CASSETTE