BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3944052 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23232
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR LOT NUMBER GD896597 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. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ON AN UNREPORTED DATE IN (B)(6) 2014, THE PT EXPERIENCED AND WAS DIAGNOSED WITH PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE, FREQUENCY NOT REPORTED) IP (INTRAPERITONEALLY) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND PERITONITIS WAS RESOLVING, AND THE PATIENT WAS RECOVERING. THE DIANEAL THERAPIES WERE ONGOING. IT WAS REPORTED THAT ON AN UNSPECIFIED FUTURE DATE, THE PT WILL BE HAVING A NEW PD CATHETER PLACED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422655 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 2.5% AND 4.25% AMBUFLEX| HOMECHOICE AUTOMATED PD SET WITH CASSETTE