BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2132092 · Received June 16, 2011

    Report

    Report Number
    1423500-2011-07735
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD883520, GD882647, GD881565 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS THE PATIENT'S MEDICAL CONDITION, GI BLEEDING. 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 1 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS, GI BLEED TWICE AND BOWEL PROBLEM IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. IT WAS UNKNOWN TO THE CONSUMER WHETHER A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. UPON A FOLLOW-UP CALL WITH THE NURSE, THE NURSE REPORTED THE FOLLOWING. ON UNREPORTED DATES, THE PATIENT EXPERIENCED GI BLEED TWICE AND A BOWEL PROBLEM WHICH THE NURSE REPORTS HAVE BEEN SOURCES OF THE PATIENT'S CASES OF PERITONITIS. PER FOLLOW UP WITH THE NURSE, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 AND DISCHARGED ON (B)(6) 2011. TREATMENT INFORMATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE EVENTS OF GI BLEED TWICE AND BOWEL PROBLEM.

    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 89 YR Hospitalization DIANEAL PD4 ULTRABAG