BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PUMP WITH SELECT-A-FLOW

    MDR report key: 9088190 · Received September 19, 2019

    Report

    Report Number
    2026095-2019-00152
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    June 29, 2019
    Report Date
    September 19, 2019
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651134722
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 0002968472 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 16 SEP 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL INC. 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). [MW5088912].

    Description of Event or Problem · 1

    FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN . INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5088912 RECEIVED ON 27-AUG-2019, AND THE FOLLOWING INFORMATION WAS PROVIDED: "THE ON-Q PUMP PAIN RELIEF SYSTEM WAS INADVERTENTLY CONNECTED TO THE PT'S HICKMAN CATHETER THAN THE RIGHT CHEST ON-Q CATHETER. WE BELIEVE THIS ERROR WAS DUE IN PART TO THE ABILITY TO EASILY CONNECT THE TWO DEVICES. THE PT'S [PATIENT'S] PAIN CONTROL WAS INITIALLY PROVIDED VIA EPIDURAL CATHETER, HOWEVER, FOLLOWING REMOVAL OF THE EPIDURAL CATHETER, THE PLAN WAS TO BEGIN CONTINUOUS PAIN RELIEF VIA THE ON-Q PAIN RELIEF SYSTEM. THE ON-Q CATHETER WAS PRESENT BUT NOT VISIBLE TO THE NURSE AND HAD NOT BEEN USED UP UNTIL THIS POINT. THE NURSE WAS UNFAMILIAR WITH ON-Q PUMPS AND ASSUMED THE ON-Q PAIN RELIEF SYSTEM SHOULD BE CONNECTED TO THE HICKMAN CATHETER. THE PT RECEIVED ROPIVACAINE VIA THE HICKMAN TIMES FOUR HOURS BEFORE THE ERROR WAS IDENTIFIED AND CORRECTED. THERE WAS NO ADVERSE OUTCOME AS A RESULT OF THIS EVENT. OUR CONCERN WAS THE ABILITY TO EASILY CONNECT THE TWO DEVICES." ADDITIONAL INFORMATION RECEIVED 09-SEP-2019 INDICATED THAT THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2019. THE PATIENT DID NOT HAVE AN ADVERSE OUTCOME AS A RESULT OF THIS EVENT; HOWEVER, "OUR CONCERN WAS THE EASE IN WHICH THE MISCONNECTION OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879771 ON-Q PUMP WITH SELECT-A-FLOW ELASTOMERIC - SAF MEB AVANOS MEDICAL - IRVINE CB004 0002968472 30680651134722

    Patients

    Seq Age Sex Outcome Treatment
    1