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

Model Number BE-HLS 7050

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2022

Event Type  malfunction  

Event Description

It was reported that blood was leaking out of the oxygenators gas outlet port after 10 minutes of application.The product was exchanged during patient treatment.Complaint id: (b)(4).

Manufacturer Narrative

The affected product was not yet received.The investigation of the manufacturer is ongoing.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported event occurred in germany.The following complaint information was provided to maquet cardiopulmonary: blood comes out of the oxygenator gas outlet ten minutes after application.A picture was provided.The affected product was investigated at the laboratory of the manufacturer.Hereby a damage at the de-airing connector was detected which led to a leakage.A leakage from the gas outlet port was not confirmed during investigation.The most probable cause of the reported failure was determined to be a leakage from the de-airing connector due to an crack caused by an external force applied to the vent connector (e.G.Tensile tress and / or lateral pressure) during or after priming of the product.Thus the reported failure "blood comes out of the oxygenator" can be confirmed.Additional a medical assessment was performed by getinge medical affairs with the following outcome: the information available is that, according to the user, 200 ml should have leaked from the gas outlet of the oxygenator of the hls set advanced 7.0 10 minutes after the start of application.Further data was not provided by the customer.Examination of the hls module advanced 7.0 did not confirm leakage from the blood to gas sides but did detect a tear/crack in the connector of the deairing membrane.This tear/crack could be the root cause of the blood loss.Since the user did not mention any leakage during priming, it can be assumed that the tear/crack occurred later.A possible explanation would be that the tear/crack was caused when the deairing membrane was closed with the yellow cap.If a luer lock cap is twisted too tightly onto the connector, such tears/cracks can occur.Other external forces may also have led to such a tear/crack.The pump cover is slightly tilted downwards towards the oxygenator housing.Also, the pump cover is not leak-proof connected to the oxygenator housing.Blood coming out of the tear/crack at the connector of the deairing membrane can therefore run along the pump cover towards the oxygenator housing and under the pump cover.This explains the blood traces at the lower end inside the pump cover.At the bottom, the blood comes out of the cover again and runs along the oxygenator housing and drips down the edge of the gas outlet.This makes it appear that the blood is dripping out of the gas outlet and explains the blood at the lower edge of the oxygenator housing.The user replaced the hls set advanced 7.0 and the patient suffered no harm as stated by the customer.The investigation report indicates that there was no leakage from the blood to the gas side.Since the user reported no leakage during priming and the leakage was detected 10 minutes after the start of perfusion, it can be assumed that force must have occurred on the deairing connector between the priming process and the blood loss.As already mentioned, this may have been due to the luer lock cap being screwed on too tightly.A deficiency in the fundamental function of the hls set advanced 7.0 can therefore be regarded as improbable.The customer will be informed about the investigation result via a getinge sales representative.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.

• 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: 15894049
• MDR Text Key: 306686174
• Report Number: 8010762-2022-00478
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701069073
• Device Lot Number: 3000238295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1