BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYHSURGPN,400X10,CBI,-,OQ,5

    MDR report key: 6673456 · Received June 28, 2017

    Report

    Report Number
    2026095-2017-00122
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    May 1, 2017
    Report Date
    June 1, 2017
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651134791
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RETURNED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202588198 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 23-JUN-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. (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: 400 ML, FLOW RATE: 10/ML/HR, PROCEDURE: MIDLINE LAPAROTOMY, CATHPLACE: RECTUS SHEATH BLOCK, DATE/TIME INFUSION START: (B)(6) 2017 PM, DATE/TIME INFUSION STOP: (B)(6) 2017 PM. A REPORT WAS RECEIVED STATING THAT FAST FLOW EVENT HAD OCCURRED. THE DEVICE WAS NOTED TO BE EMPTY WITHIN 24 HOURS OF INITIAL START. ADDITIONAL INFORMATION RECEIVED 14-JUN-2017 STATED THE NURSE DISCOVERED THE EMPTY DEVICE. THE PATIENT WAS ON THE SURGICAL HIGH DEPENDENCY UNIT. THE PATIENT WAS NOT RECEIVING WARMING OR COOLING THERAPY. THE PUMP AND TUBING WAS NOT UNDER A WARMING OR COOLING DEVICE. THE PUMP WAS PLACED UNDER THE BLANKETS BELOW THE INFUSION SITE DURING INFUSION. THERE WAS NO REPORTED INJURY. NO FURTHER INFORMATION TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453725 HYHSURGPN,400X10,CBI,-,OQ,5 ELASTOMERIC LFR MEB HALYARD - IRVINE CBI002 0202588198 30680651134791

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR