BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2063400 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04713
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    June 1, 2009
    Report Date
    March 25, 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). THIS REPORT ADDRESSES THE SECOND REPORT OF PERITONITIS. THIS IS REPORT 3 OF 4 FOR THE SECOND INCIDENCE OF REPORTED PERITONITIS. AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBERS GD865170, GD866046 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ASSIGNABLE CAUSE OF THE REPORTED PROBLEM OF PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    BAXTER'S GLOBAL PHARMACOVIGILANCE (GPV) CONTACTED THE HOME PATIENT(HP) TO FOLLOW UP ON AN UNRELATED ALARM COMPLAINT. THE HP REPORTED THAT HE HAD 2 EPISODES OF PERITONITIS 6 MONTHS APART FROM ONE ANOTHER IN 2009. HE COULD NOT RECALL THE CULTURE RESULTS FOR THESE PERITONITIS INCIDENTS. BAXTER CONTACTED THE PD RN ON 12 APRIL 2011 AND SHE REPORTED THAT SHE HAD NO INFORMATION AVAILABLE REGARDING THESE PERITONITIS INCIDENTS AS THE INFORMATION FOR THE YEAR 2009 HAS BEEN ARCHIVED. NO FURTHER INFORMATION WAS AVAILABLE.

    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 65 YR Other DIANEAL LOCAL (PD4) AMBUFLEX| HOMECHOICE