BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 3041471 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08745
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONSUMER REPORTED THAT THE PATIENT HAD BEEN IN AND OUT OF THE HOSPITAL FOR THE EVENT OF PERITONITIS. THE NURSE CLARIFIED THE HOSPITALIZATION DATE FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH AN INTRAPERITONEAL INJECTION OF CEFTAZIDIME. SIX DAYS AFTER ADMISSION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE NURSE REPORTED THAT ON (B)(6) 2013, THE PATIENT EXPERIENCED THE START OF THE PERITONITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 12K14H25 AND 12J16H25 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. (B)(40.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 5 FOR THIS PERITONITIS EVENT. IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS THE PATIENT'S PAST MEDICAL HISTORY OF DIVERTICULITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH GENTAMICIN AND VANCOMYCIN, INTRA-PERITONEALLY (DOSAGE WAS NOT REPORTED). PD THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142717 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention DIANEAL AMBUFLEX, DIANEAL ULTRABAG, AND EXTRANEAL