BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALINDROME

    MDR report key: 6371559 · Received March 2, 2017

    Report

    Report Number
    3009211636-2017-05018
    Event Type
    Death
    Date Received
    March 2, 2017
    Date of Event
    February 15, 2017
    Report Date
    February 16, 2017
    Manufacturer
    COVIDIEN MANUF. SOLUTIONS SA
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/02/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE IS NO NONCONFORMANCE RECORDS (NCRS) RELATED TO THE REPORTED ISSUE. ALL DHRS ARE REVIEWED FOR ACCURACY PREVIOUS TO PRODUCT RELEASE. NO SAMPLE WAS RECEIVED FOR EVALUATION. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO PERFORM A SAMPLE EVALUATION AS PART OF A COMPREHENSIVE INVESTIGATION. IF A SAMPLE IS RECEIVED, THIS COMPLAINT WILL BE UPDATED WITH THE ADDITIONAL INFORMATION. PER THE AVAILABLE INFORMATION, THE REASON OF THE Y - CONNECTOR DETACHMENT COULD NOT BE CONFIRMED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. IT MUST BE NOTED THAT THIS KIT CONTAINS SEPARATED COMPONENTS THAT ARE TO BE ASSEMBLED BY THE DOCTOR/NURSE WHEN IT IS GOING TO BE USED. WITH THE AVAILABLE INFORMATION AND BASED ON THE EVENT¿S ANALYSIS, THE MOST PROBABLE CAUSES ARE RELATED TO USAGE (IMPROPER USER ASSEMBLY OR EXCESSIVE FORCE OR JERKING MOTIONS DURING USE). THIS IS BASED ON THE FACT THAT THE DEVICE WAS IMPLANTED DURING THE REPORTED AMOUNT OF TIME, THEREFORE, MOST LIKELY, THE DEVICE FUNCTIONED AS INTENDED AND COULD BE DAMAGED DURING USE. ALL PREVIOUSLY MENTIONED SITUATIONS MAY CAUSE THE CATHETER TO SNAP APART, BUT THE LIMITED INFORMATION DOES NOT ALLOW CONFIRMING A PARTICULAR CAUSE. A TREND AND TRIGGER ANALYSIS WAS PERFORMED TAKING INTO CONSIDERATION THE REPORTED COMPLAINTS FOR THIS FAILURE MODE AND NO TRENDS OR TRIGGERS WERE FOUND. IT MUST BE NOTED THAT IN-PROCESS CONTROLS, SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING, ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. AS PER PROCEDURE, MANUFACTURING PERFORMS A 100% VISUAL ASSEMBLY FINAL INSPECTION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 02/16/2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES A FEMALE PATIENT INFORMED HER HOUSE DOCTOR THERE WAS A MINIMAL LEAK, LIKE A DROP ON THE EXIT. WHEN THE DOCTOR CAME IN, THE Y-PART OF THE CATHETER WAS LYING BESIDE THE PATIENT, INSIDE THE BANDAGE. THIS LED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6)2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES A FEMALE PATIENT INFORMED HER HOUSE DOCTOR THERE WAS A MINIMAL LEAK, LIKE A DROP ON THE EXIT. WHEN THE DOCTOR CAME IN, THE Y-PART OF THE CATHETER WAS LYING BESIDE THE PATIENT, INSIDE THE BANDAGE. THIS LED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154248 PALINDROME CATHETER, HEMODIALYSIS, IMPLANTED MSD COVIDIEN MANUF. SOLUTIONS SA 8888541023P 1616000232

    Patients

    Seq Age Sex Outcome Treatment
    1 Death