BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2120637 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07451
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD879924 WHICH REVEALED VOIDS WERE NOTED IN THE POUCH SEAL DURING MANUFACTURING. CORRECTIVE ACTIONS WERE IMPLEMENTED BY THE MANUFACTURING FACILITY AND A RE-INSPECTION OF THE LOT WAS PERFORMED WHICH REVEALED ALL AFFECTED UNITS WERE REMOVED PRIOR TO RELEASE OF THE LOT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE IN 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (LOT NUMBER, DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING INFORMATION WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. IT WAS NOT REPORTED IF A PERITONEAL EFFLUENT CULTURE WAS DONE. TREATMENT WAS NOT REPORTED. RECOVERY STATUS WAS NOT REPORTED. THE NURSE STATED THAT THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION.

    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 46 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE DEVICE