BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2162479 · Received July 14, 2011

    Report

    Report Number
    1423500-2011-09035
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER 10L14H25 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS PATIENT MEDICAL CONDITION. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. 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 A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF INFECTION FROM DIVERTICULITIS AND PERITONITIS WITH CULTURE POSITIVE FOR KLEBSIELLA PNEUMONIAE COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE CONSUMER AND THE NURSE. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED INFECTION FROM DIVERTICULITIS. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011 FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS INFECTION FROM DIVERTICULITIS. THE PATIENT WAS BEING TREATED WITH UNSPECIFIED ANTIBIOTICS. ADDITIONAL TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND THE OUTCOME FOR THE INFECTION FROM DIVERTICULITIS WAS NOT REPORTED. DIANEAL THERAPIES WERE ONGOING. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPIES AND WAS DUE TO THE INFECTION FROM DIVERTICULITIS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE INFECTION FROM DIVERTICULITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX