BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2051484 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04385
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS GD882241 AND GD881417 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PHYSICIAN REPORTED THE FOLLOWING INFORMATION. IN (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE CAUSE OF THE PERITONITIS AND TREATMENT WERE NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT'S PD CATHETER WAS REMOVED. THE PATIENT HAD BEEN OFF THE PD SOLUTIONS FOR ABOUT A WEEK OR TWO NOW. ON AN UNREPORTED DATE, THE PATIENT WAS PLACED ON HEMODIALYSIS. IN (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING FROM THE PERITONITIS. PER THE PHYSICIAN, THE PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA WAS UNRELATED TO DIANEAL AND EXTRANEAL THERAPIES.

    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 66 YR Hospitalization DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX| HOMECHOICE