BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3782006 · Received April 30, 2014

    Report

    Report Number
    1416980-2014-14003
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION, AND A REQUEST FOR ITS RETURN HAS BEEN MADE. A REVIEW OF ALL BATCH RECORD DOCUMENTS 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. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION ALONG WITH 50 SEALED, UNUSED DEVICES OF THE SAME LOT. ALL OF THE SAMPLES PASSED UNDERWATER LEAK TESTING (IN WHICH THE DEVICE WAS PRESSURIZED AND OBSERVED FOR RISING AIR BUBBLES) AND CONNECTION ISSUE TESTING (IN WHICH THE DEVICE WAS CONNECTED TO A COMPATIBLE SET CONNECTOR). THE DIMENSIONS OF ALL THE SAMPLES WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. VISUAL INSPECTION WAS THEN PERFORMED ON ALL OF THE SAMPLES; A SLIGHT CRACK WAS IDENTIFIED ON THE USED DEVICE AND NO ISSUES WERE IDENTIFIED WITH ANY OF THE UNUSED DEVICES. THE CAUSE OF THE CRACK WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP WITH POVIDONE IODINE SOLUTION LEAKED IODINE FROM A CRACK ON ITS SIDE. THIS WAS NOTICED BY THE PATIENT WHEN THE IODINE STAINED THEIR SHIRT, 2 TO 3 HOURS AFTER THE DEVICE WAS USED TO CAP A MINICAP EXTEND LIFE PD TRANSFER SET WITH TWIST CLAMP (BAXTER PRODUCT) TO ABORT THE PATIENT¿S CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE REPORTER STATED THAT NO LEAKAGE WAS OBSERVED FROM THE TRANSFER SET DURING THE THERAPY OR DURING THE 2 TO 3 HOURS WHILE IT WAS CAPPED. THERE WAS NO REPORT OF DAMAGE TO THE MINICAP¿S OUTER PACKAGING. THE REPORTER STATED THAT THE PATIENT USED THE PROPER CONNECTION TECHNIQUE OF TWISTING THE MINICAP ONTO THE TRANSFER SET CONNECTOR UNTIL FIRMLY SECURE; THERE WAS NO DIFFICULTY ENCOUNTERED WHILE CONNECTING, THE MINICAP WAS NOT OVERTIGHTENED, AND AN ASSIST DEVICE WAS NOT USED TO MAKE THE CONNECTION. NO CLEANING SOLUTIONS WERE USED ON THE MINICAP OR TRANSFER SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260139 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 13K25H15

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR MINICAP EXTENDED LIFE PD TRANSFER SET (R5C4482)