BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3002805 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06052
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 19, 2013
    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). ADDITIONAL INFORMATION: THE REPORTED CONDITION WAS NOT CONFIRMED, AS NO SAMPLES WERE RETURNED TO BAXTER. THEREFORE, A CAUSE WAS NOT IDENTIFIED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER, HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBERS GD893867 AND GD893461 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT EXPERIENCED PERITONITIS WAS HOSPITALIZED FOR THE EVENT. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE, ROUTE, AND FREQUENCY NOT REPORTED). WHEN THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL, THE PATIENT WAS INSTRUCTED TO TAKE CEFAZOLIN, 1000MG INTRAPERITONEALLY (IP) FOR 14 DAYS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. PD THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. SAME PATIENT AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105633 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX| EXTRANEAL