BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 2243376 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12061
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 24, 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 FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD886036, GD885285 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE USE ERROR WHICH RESULTED IN THE PERITONITIS WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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 REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT EXPERIENCED BEING CONSTIPATED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS CONSTIPATION. TREATMENT INFORMATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. ON AN UNREPORTED DATE IN (B)(6) 2011, DIANEAL THERAPY WAS WITHDRAWN. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE EVENT OF CONSTIPATED. THE ADVERSE EVENT OF FAILURE TO WEAR A MASK WAS ADDED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A FAILURE TO WEAR A MASK. THE CAUSE OF THE PERITONITIS WAS EITHER THE PATIENT'S FAILURE TO WEAR A MASK DURING PD PROCEDURES OR THE PATIENT'S HISTORY OF CONSTIPATION ISSUES THAT WERE ONGOING. TREATMENT AND OUTCOME FOR THE EVENT OF FAILURE TO WEAR A MASK WERE NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND WAS RECOVERING FROM THE PERITONITIS AND CONSTIPATION. ON (B)(6) 2011, DIANEAL THERAPY WAS WITHDRAWN. THE GASTROPARESIS AND CONSTIPATION ISSUES HAD NOT WORSENED SINCE THE START OF PD. THE NURSE REPORTED THAT THE EVENTS OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) AND CONSTIPATED WERE NOT RELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF FAILURE TO WEAR A MASK.

    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 73 YR Hospitalization DIANEAL PD4 ULTRABAG