BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2122926 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07595
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (GD882241, GD883108). THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF BOWEL OBSTRUCTION THAT CAUSED E. COLI AND PERITONITIS WITH CULTURE POSITIVE FOR E. COLI IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPY (LOT NUMBER, DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE CONSUMER. ON AN UNREPORTED DATE IN 2011, THE PATIENT HAD BOWEL OBSTRUCTION THAT CAUSED E COLI. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE IN 2011, A PERITONEAL EFFLUENT CULTURE REVEALED E COLI. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND THE OUTCOME FOR THE BOWEL OBSTRUCTION THAT CAUSED E COLI WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT REPORTED.

    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 46 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE DEVICE