BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2023884 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03401
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD881474, GD880781 AND GD879916 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 4 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A NURSE IN THE USA OF IMMUNE SYSTEM IS VERY LOW, CATHETER CULTURE POSITIVE FOR GRAM NEGATIVE RODS AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX (LOT NUMBERS, DOSES, AND FREQUENCIES NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE REPORTED THE FOLLOWING. ON AN UNKNOWN DATE, THE PATIENT STARTED CHEMOTHERAPY FOR AN UNREPORTED INDICATION AND EXPERIENCED A LOW IMMUNE SYSTEM. ON AN UNREPORTED DATE, THE PATIENT DEVELOPED PERITONITIS. IN (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF TREATMENT WAS PROVIDED FOR THE EVENTS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERING FROM THE LOW IMMUNE SYSTEM, OR CATHETER WITH CULTURE POSITIVE FOR GRAM NEGATIVE RODS (GNRS). CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS NOT REPORTED IF ACTION WAS TAKEN WITH THE ASSOCIATED PRODUCTS. THE NURSE REPORTED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL AND EXTRANEAL THERAPIES. THE CAUSALITY FOR THE EVENT OF IMMUNE SYSTEM IS VERY LOW AND CATHETER WITH CULTURE POSITIVE FOR GNRS WAS NOT REPORTED IN RELATION TO DIANEAL THERAPY. THE NURSE STATED THE LOW IMMUNE SYSTEM WAS DUE TO THE CHEMOTHERAPY. THE CHEMOTHERAPY WAS CONSIDERED A SUSPECT PRODUCT. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2011 FROM THE PD NURSE. ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND WAS HOSPITALIZED THE SAME DAY. ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT SIGNED HIMSELF OUT OF THE HOSPITAL AGAINST MEDICAL ADVICE (AMA). ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT WAS RE-HOSPITALIZED FOR FOLLOW UP FOR PD THERAPY. ON (B)(6) 2011, THE PATIENT'S CATHETER WAS REMOVED AND DIANEAL AND EXTRANEAL THERAPIES WERE DISCONTINUED. ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT STARTED HEMODIALYSIS THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED.

    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 43 YR Hospitalization EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX