MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HLS SET

Device Problems Misconnection (1399); Misassembly by Users (3133)

Patient Problem Air Embolism (1697)

Event Date 01/02/2023

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

It was reported that the green gas tube was connected to the de airing membrane which results into an air embolism and the death of the patient.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the green gas tube was connected from a nurse (hospital staff) to the de-airing membrane which results into an air embolism and the death of the patient.The affected product was technically investigated in the getinge laboratory on 2023-03-09.The affected hls module was received with the following connected components: ¿ two sample lines with three-way stopcocks (blood inlet side and luer blood outlet connector) ¿ a luer cap on the quick-vent ¿ gas hose with gas filter and luer cap on the gas inlet of the outer cover during visual inspection no abnormalities could be detected at the hls module.In addition the following specification were checked and could be confirmed: ¿ the product labels were present according to specifications, correct in terms of content and correctly positioned.¿ the lettering "gas in" on the outer cover was clearly visible / legible.¿ the components gas hose + gas filter at the gas inlet of the outer cover were present.Comparison with specification was carried out without any objections.During the technical investigation of the hls set advanced 7.0 no malfunction could be determined.The product labels were present as specified, with correct content and correctly positioned and the lettering "gas in" on the outer lid was clearly visible / legible.During the technical investigation, no deviations or other signs were found on the hls module and the available hls components, which could have favored or explained a connection of the gas supply to the hls module that was not intended for this purpose.In addition a medical review was performed by getinge medical affairs on 2023-03-13 with the following outcome: the deairing membrane is a semipermeable membrane and is used during the priming process to allow air to escape from the oxygenator to make the blood side of the oxygenator completely air-free for later use.After deairing the hls set advanced 7.0, a new sterile yellow cap included in the hls set package must be used to close this opening.Not doing so may result in air being entrained into the blood path of the circuit.The deairing membrane is a semipermeable membrane and is used during the priming process to allow air to escape from the oxygenator to make the blood side of the oxygenator completely air-free for later use.After deairing the hls set advanced 7.0, a new sterile yellow cap included in the hls set package must be used to close this opening.Not doing so may result in air being entrained into the blood path of the circuit.The necessary closure of the deairing membrane after the priming procedure is referred to under the chapters ¿safety instructions for the oxygenator¿ and ¿application¿ in the instruction for use.The green gas tube has to be connected to the white gas filter, which is fixed to a short green gas tube which is already connected to the gas inlet of the oxygenator by the manufacturer.The gas inlet is connected to the gas side of the oxygenator, which keeps the gas separate from the blood side.In the event of this complaint the gas mixture set using the sechrist gas blender was given directly into the blood side of the extracorporeal circuit via the deairing membrane due to the connection between the gas blender and the deairing membrane via the green gas tube.It is assumed that in this way a large amount of gas entered the patient's bloodstream within a very short time.This resulted in a gas embolism from which the patient expired as described by the customer.Related to the investigation results of the hls set advanced 7.0 by the life cycle team of getinge, a malfunction of the hls set can be ruled out.The attachment of the green gas tube to the deairing membrane of the oxygenator appears to have resulted in the gas mixture being administered directly into the bloodstream of the patient, causing the patient to expire of a gas embolism.Based on the investigation results the reported failure could be confirmed but was not related to a product malfunction.The most possible root cause could be determined as user error of application of the product.The production records of the affected be-015703112 #shls module advanced adult were reviewed on 2022-01-18 for the reported failure.According to the final test results, the be-015703112 #shls module advanced adult passed the tests as per specifications.Production related influences are unlikely.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id (b)(4).

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16129892
• MDR Text Key: 306981613
• Report Number: 3008355164-2023-00004
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2023
• Distributor Facility Aware Date: 03/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2023
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death