BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2760963 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00784
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT. A BATCH REVIEW WAS PERFORMED, AND NO ISSUES WERE DETECTED DURING THE MANUFACTURING OF LOTS GD892380, GD892372 AND GD891994.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A NURSE IN (B)(6) OF SHORTNESS OF BREATH AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, APPROXIMATELY THE WEEK OF (B)(6) 2012, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND CLOUDY PD EFFLUENT. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR SHORTNESS OF BREATH. THE PATIENT RECEIVED UNSPECIFIED ANTIBIOTICS FOR THE EVENT. ON AN UNREPORTED DATE, DURING THE HOSPITALIZATION THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF PERITONITIS AND SHORTNESS OF BREATH WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

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