BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2920779 · Received January 17, 2013

    Report

    Report Number
    1416980-2013-01293
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 12G18H25 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY CONSUMER IN THE USA OF PUS CAPSULED ON ONE SIDE OF THE CATHETER, PERITONITIS, AND WOUND IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPIES WAS NOT REPORTED. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD AN ENDOSCOPY AND FOUND THAT A 1/2 LB. OF PUS HAD CAPSULED ON ONE SIDE OF THE CATHETER. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT'S CATHETER WAS REMOVED, WHICH CAUSED A WOUND. WHILE HOSPITALIZED, THE PATIENT WAS GIVEN ANTIBIOTICS (UNSPECIFIED). THE WOUND WAS STILL HEALING. THE PATIENT WAS CLEANING HER CATHETER REALLY WELL. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME FOR THE EVENT OF PUS CAPSULED ON ONE SIDE OF THE CATHETER WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND THE WOUND. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26384 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| HOMECHOICE