BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3233397 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18863
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD894295 AND GD894410 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS NOT AVAILABLE; THEREFORE, A SAMPLE ANALYSIS CANNOT BE COMPLETED. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE HOME PATIENT (HP) EXPERIENCED A RECURRENT PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT ALWAYS PRACTICED CLEAN PROCEDURES WHEN PERFORMING A THERAPY. THE PATIENT TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PD THERAPY WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE PATIENT WAS FULLY RECOVERED FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS TREATED WITH GENTAMYCIN (ROUTE, DOSE AND FREQUENCY NOT REPORTED). AT THE TIME OF THIS REPORT, THE PATIENT RECOVERED FROM PERITONITIS. THE PATIENT WAS RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333117 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention HOMECHOICE AUTOMATED PD SET WITH CASSETTE| MINICAP TRANSFER SET, DIANEAL PD4 4.25% AMBUFLEX| DIANEAL PD4 2.5% AMBUFLEX| HOMECHOICE, DIANEAL UNKNOWN