BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 2183464 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09960
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS: GD883942, AND GD885301 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. 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 2 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE WITH SUPPLEMENTAL INFORMATION BY A CONSUMER FROM THE USA OF PERITONITIS AND HERNIA IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A HERNIA WHICH WAS "WRAPPED AROUND HER CATHETER CAUSE SOMETHING TO PUSH INTO HER JUGULAR VEIN". TREATMENT AND OUTCOME WERE NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE NURSE STATED THE PATIENT WAS HOSPITALIZED FOR PERITONITIS ON AN UNREPORTED DATE IN (B)(6) 2011. DURING THE HOSPITALIZATION, THE PD CATHETER WAS REMOVED FOR AN UNKNOWN CAUSE AND THE PATIENT WAS PLACED ON BACK-UP HD (HEMODIALYSIS). IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO PD THERAPY AND DID NOT COMMENT ON THE HERNIA AS REPORTED BY THE CONSUMER. THE NURSE DECLINED TO PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization DIANEAL PD4 AMBUFLEX