BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2122876 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07578
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD883082 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. 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 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF HYPOTENSION AND (B)(6) PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG, AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED HYPOTENSION. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE HYPOTENSION. ON AN UNREPORTED DATE WHILE HOSPITALIZED, THE PATIENT EXPERIENCED (B)(6) PERITONITIS. TREATMENT DURING HOSPITALIZATION WAS NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT RECOVERED FROM THE EVENT OF HYPOTENSION. THE PATIENT WAS RECOVERING FROM THE EVENT OF (B)(6) PERITONITIS. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. THE NURSE REPORTED THAT THE HYPOTENSION AND (B)(6) PERITONITIS WERE 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 64 YR Other DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG| EXTRANEAL VIAFLEX| HOMECHOICE