MAUDE Adverse Event Report: CARDINAL HEALTH MALTA 212 LTD FLEX ADVANTAGE LINER 3000ML; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651936

Device Problems Suction Problem (2170); Misassembly by Users (3133)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/09/2020

Event Type  Death  

Manufacturer Narrative

Investigation into this reported incident is on-going while we continue to gather further details related to the event.A follow-up report will be filed once the results have been completed.

Event Description

The suction canister with liner is used without a stand keeping it vertical and can be lying down or shocked at any time during resuscitation.This may result in the safety valve being clamped on the outlet and thereby stopping the suction.Lack of information on the device, on the risk of stopping the vacuum.This type of event was suspected during loss of suction during cpr (cardiopulmonary resuscitation) in emergencies, having resulted in eigas (serious adverse event related to treatment) death of patient.

Manufacturer Narrative

Supplemental report being filed since investigation results available.Based on the information provided, it has been determined that the assignable root cause was related to improper set-up of the flex advantage system.It was clear from the complaint and subsequent follow-up meetings with the hospital that the device was not correctly set up as per the instructions for use.The device instructions for use (ifu) states, ¿if not already in a mounting bracket, place reusable hard canister into bracket on a roll stand or wall mount.Device is to be used in vertical orientation only.¿ the device was not correctly set up as per the ifu.The contact person confirmed the device wasn¿t in its support and was not set up correctly.A revision to the ifu is in-progress which entails an amendment in the description section to illustrate that ¿a mechanical shut off device acts as a shut off valve when in contact with fluids, disabling the vacuum system if the maximum filling level is reached or if the unit is not completely in its vertical orientation.¿ warning section of ifu was also revised to illustrate that ¿a premature shut off of the device could result in life threatening or serious injury.¿ more information in the warning section was added to illustrate ¿the liner shut-off mechanism is angle sensitive and designed to stop the vacuum anytime it is not in a vertical position¿ added trouble shooting section to illustrate that customer should ¿ensure liner is placed in a reusable hard canister either attached to a wall mount or in roll stand to ensure proper position of the device.Device must be in a vertical position at all times.(see set-up procedure) to avoid premature shut off.¿ cardinal health representative provided the facility with all of the videos and poster to make sure the users have the ability to keep track of the setup needed.The posters in french were generated prior to (b)(6) 2020 and circulated to all customer¿s in france.The posters, ifu and setup guides (video) have been shared with chu de toulouse hospital in september.It was confirmed that training is carried out to all staff that would be using these devices when installation is carried out in the or and in wards.Cardinal health is arranging a workshop with the care manager in this hospital to explore best practices when possible due to covid.

• Brand Name: FLEX ADVANTAGE LINER 3000ML
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• MDR Report Key: 10468639
• MDR Text Key: 204859355
• Report Number: 1423537-2020-00505
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 65651936
• Device Catalogue Number: 65651936
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 95 YR