BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3803086 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15036
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896191 AND GD896209 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THREE DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PT WAS HOSPITALIZED FOR THE EVENT. THE PT RECEIVED TREATMENT FOR THE PERITONITIS WITH CEFTAZIDIME (1 GRAM, INTRAPERITONEALLY (IP) FOR 10 DAYS) AND VANCOMYCIN (500MG, IP, EVERY OTHER DAY FOR 10 DAYS). SIX DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE PT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE EVENT AND DIANEAL THERAPIES WERE ONGOING. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281814 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL PD4, 1.5% AMBUFLEX| MINICAP TRANSFER SET| DIANEAL PD4, 4.25% AMBUFLEX| DIANEAL PD4, 2.5% AMBUFLEX