BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2063448 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04719
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 1, 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). 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 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (GD881417, GD882241), WITH NO DEFECTS NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE WITH SUPPLEMENTAL INFORMATION BY A CONSUMER FROM THE USA OF PAIN, PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS VIRIDANS, UNSTABLE ANGINA, MENTAL STATUS CHANGES, PNEUMONIA AND STREPTOCOCCAL SEPTICEMIA IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE THE NURSE REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2011, THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH STREPTOCOCCAL SEPTICEMIA AND PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENTS. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED AND HOSPITALIZED FOR PAIN, MENTAL STATUS CHANGES AND PNEUMONIA. IN 2011, WHILE HOSPITALIZED, THE PATIENT EXPERIENCED AN IRREGULAR HEARTBEAT THAT WAS CONFIRMED BY THE NURSE AS UNSTABLE ANGINA. TREATMENT RENDERED WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. ON (B)(6) 2011 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERING FROM THE PAIN, MENTAL STATUS CHANGES AND UNSTABLE ANGINA. THE OUTCOME OF THE STREPTOCOCCAL SEPTICEMIA AND PERITONITIS WAS NOT REPORTED. PER THE NURSE, THE STREPTOCOCCAL SEPTICEMIA, PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS VIRIDANS, PAIN, MENTAL STATUS CHANGES, PNEUMONIA, AND UNSTABLE ANGINA WERE UNRELATED TO DIANEAL THERAPY.

    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 73 YR Other DIANEAL PD4 ULTRABAG