BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 2181677 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09843
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 6, 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). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS: GD885277 AND GD884437 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 1 OF 2 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 CONSUMER FROM THE USA OF "FLUID ON LUNGS" PERITONITIS, CONSTIPATED, MERCER AND SMALL AMOUNT OF BLOOD IN BAG IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING INFORMATION WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED "FLUID ON LUNGS." ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE AFOREMENTIONED EVENT. ON AN UNREPORTED DATE, DURING A PREVIOUS HOSPITALIZATION, THE PATIENT EXPERIENCED MERCER. IN (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON UNREPORTED DATES, THE PATIENT EXPERIENCED BEING CONSTIPATED, SMALL AMOUNT OF BLOOD IN BAG, AND BAGS ARE A LITTLE CLOUDY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION FOR THE EVENTS OF PERITONITIS, CONSTIPATED AND SMALL AMOUNT OF BLOOD IN BAG. INFORMATION PERTAINING TO TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. OUTCOME FOR THE EVENTS OF MERCER, CONSTIPATED, AND SMALL AMOUNTS OF BLOOD IN BAG WERE NOT REPORTED. DIANEAL PD4 ULTRABAG THERAPY WAS ONGOING. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENTS OF MERCER, PERITONITIS, CONSTIPATED, SMALL AMOUNT OF BLOOD IN BAG AND THE RELATION TO DIANEAL PD4 ULTRABAG THERAPY. THE CONSUMER STATED THAT HE WAS NOT SURE OF THE CAUSE OF THE PERITONITIS, HOWEVER, THOUGHT IT MAY HAVE BEEN CAUSED BY THE (B)(6) INFECTION HE HAD DURING HIS LAST HOSPITALIZATION. .

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other DIANEAL PD4 ULTRABAG