BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 2251737 · Received September 16, 2011

    Report

    Report Number
    1423500-2011-12330
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 29, 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). 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. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS : GD886804, GD886028, AND GD884445 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. 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.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT EXPERIENCED BEING NAUSEOUS, VOMITING AND ABDOMINAL PAIN. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE NURSE REPORTED, THAT ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS OF NAUSEOUS AND VOMITING NOT PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH UNSPECIFIED ANTIBIOTICS. ON AN UNREPORTED DATE IN (B)(6) 2011, THE BACTERIAL PERITONITIS WAS RESOLVING. THE NURSE STATED THAT ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA AND VOMITING THAT RESULTED IN HOSPITALIZATION ON THE SAME DAY. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THE NURSE STATED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR (B)(6), ABDOMINAL PAIN, NAUSEA AND VOMITING WERE UNRELATED TO DIANEAL THERAPY. THE NURSE STATED THAT THE ABDOMINAL PAIN, NAUSEA AND VOMITING WERE RELATED TO THE PATIENT'S MEDICAL HISTORY OF GALLBLADDER ISSUES AND PEPTIC ULCER DISEASE.

    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 49 YR Hospitalization| R DIANEAL PD4 AMBUFLEX.