BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1812057 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02801
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    June 1, 2009
    Report Date
    August 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD861971 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WITH 2-CELL SCREEN ON THE GALILEO INSTRUMENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHOSE NURSE REPORTED PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. DURING A FOLLOW-UP CALL, ON (B)(6) 2010, THE NURSE PROVIDED THE FOLLOWING INFORMATION. ON (B)(6) 2009, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AFTER AN EFFLUENT CULTURE, OBTAINED THE SAME DAY, (B)(6). THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE NURSE COULD NOT REMEMBER IF THE PATIENT HAD CLOUDY EFFLUENT AT THE TIME OF THE DIAGNOSIS. ON AN UNREPORTED DATE IN (B)(6) 2009, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (UNSPECIFIED) ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED). IN (B)(6) 2009, THE ANTIBIOTIC REGIMEN WAS COMPLETED. ON (B)(6) 2009, A REPEAT EFFLUENT CULTURE SHOWED "(B)(6)". ON (B)(6) 2009, THE EVENT OF PERITONITIS RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention