MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CRD FLEX 3000CC CANISTER WITH VALVE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65652-631A

Device Problems Use of Device Problem (1670); Suction Problem (2170)

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 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

Follow up report is being filed, since the results of the investigation are now available.A thorough investigation into the incident reported, has been completed regarding the outer canister used with a disposable liner.Based on the information obtained from the healthcare facility in france.It was determined, that the canister was not placed into a wall bracket or roll stand as stated, in the directions for use.Therefore, the device failed to work as intended.The dfu under setup states, "if not already in a mounting bracket, place reusable hard canister into a bracket on a roll stand or wall mount.Device is to be used in vertical orientation only".Canister shut off and suction stopped since device was used without the holder to maintain vertical position as required.The product worked as designed.Cardinal health¿s manufacturing team will be adding an orientation arrow onto the canister, that will help the end users who do not necessarily see the instructions for use (ifu) on proper setup of the canister, with liner setup to prevent improper setup.

• Brand Name: CRD FLEX 3000CC CANISTER WITH VALVE
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 10468687
• MDR Text Key: 204854753
• Report Number: 1423537-2020-00506
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10885380158612
• UDI-Public: 10885380158612
• 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: 12/23/2020

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: 65652-631A
• Device Catalogue Number: 65652-631A
• 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