BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGPN,400X200,HM PMP,-,EC,10

    MDR report key: 6606063 · Received June 1, 2017

    Report

    Report Number
    2026095-2017-00104
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    March 23, 2017
    Report Date
    July 11, 2017
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: EVENT DAE (B)(6) 2017. ALL INFORMATION REASONABLY KNOWN AS OF 4-AUG-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202390338, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 30-MAY-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    FILL VOLUME: 400 ML, FLOW RATE: 200 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2017-00103 FOR THE FIRST REPORT. FOR THE SECOND EVENT IT WAS REPORTED FROM (B)(6) THE NURSES THEN FILLED THE DEVICE TO 400ML IN ORDER TO OVERCOME THIS ISSUE BUT THE PRODUCTS INFUSED IN 1 HOUR AND 20 MINUTES. THE DEVICE WAS USED IN A ROOM TEMPERATURE ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387862 SURGPN,400X200,HM PMP,-,EC,10 ELASTOMERIC HFR MEB HALYARD - IRVINE E402000-10 0202390338

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR