BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3801917 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14875
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    December 1, 2013
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) GD895565 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, DIARRHEA, AND ABDOMINAL CRAMPS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. THE PT WAS REPORTED TO BE RECOVERING FROM THE EVENT. TREATMENT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 2 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281616 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MINICAP TRANSFER SET| EXTENSION SET| CAPD DISCONNECT Y SET| DIANEAL PD4 1.5%. 2.5% AND 4.25% AMBUFLEX| HOMECHOICE| DIANEAL PD4 2.5% ULTRABAG| HOMECHOICE AUTOMATED PD SET WITH CASSETTE