BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3181640 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16117
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE ACTUAL SAMPLE IS NOT AVAILABLE, HOWEVER, COMPANION SAMPLES HAVE BEEN REQUESTED. SHOULD THE SAMPLES BE RECEIVED AND AN EVALUATION COMPLETED OR ADDITIONAL INFORMATION RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, COMPANION DEVICES WERE RECEIVED. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE COMPANION DEVICES. THE DEVICES MET ALL SPECIFICATIONS FOR THE CRITICAL DIMENSIONS. NO ISSUES WERE FOUND WITH THE COMPANION DEVICES. THE CAUSE COULD NOT BE DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR LOT NUMBER 12K27H17 WAS PERFORMED 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP BECAME LOOSE AND POVIDONE IODINE LEAKED FROM THE JUNCTION BETWEEN THE MINICAP AND THE TRANSFER SET DURING USE FOR PERITONEAL DIALYSIS (PD) THERAPY. THIS IS REPORT 2 OF 4 IN THIS EVENT. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283127 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 12K27H17

    Patients

    Seq Age Sex Outcome Treatment
    1 MINICAP TRANSFER SET