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

Model Number BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 11/30/2022

Event Type  Death  

Manufacturer Narrative

The affected cardiohelp will be investigated in complaint# (b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Following was initially reported : ¿ the hls module advanced performed as it was designed.I was not present and do not know the exact circumstances, my information came to me all second hand.It was reported to me that a large amount of air entered the venous air from an unknown source.Once the centrifugal pump saw that amount of venous air it triggered an automatic pump stop.I was told that the ecls provider assigned to the case wasn't able to resolve the venous air situation on their own, so the ecls coordinator was called down to help.Her name is anna hansen.I was told that once anna arrived the patient had been off support for longer than 6 minutes.It was noted that the air was removed from the venous line, and the circuit was again ready to be used in the proper manner.Unfortunately, the medical providers determined that to much time had passed from the time the patient went off support to the time the circuit was again ready for use.A decision was made to withdraw mechanical hls and cardiohelp support from the patient.Subsequently the patient expired.I was told that the hospital was performing an autopsy.I was also told that the providers conducting the autopsy also performed an underwater test on the hls module advanced and they determined that the circuit didn't have any leaks or compromised integrity of any kind.The ecls coordinator also informed me that she had sequestered the cardiohelp that was used during the case.Our getinge service technician (tony lockett) was contacted and is scheduled to perform an inspection and information download of the cardiohelp on (b)(6) 2022.The cardiohelp that was used during this case was not found to have any issues related to it.Its serial number is: (b)(4).The hospital staff did pull this cardiohelp out of service and set it aside until our getinge representative could come in and downloaded the keystrokes, and all available data from the case to add to the investigation report.Tony lockett is the getinge service technician for this region, he has been contacted and will be on site on tuesday (b)(6).The customer asked me the question "could the hls module advanced have been malfunctioning or possibly the cause of the air?" i informed her that i would be able to definitively give an answer to that question without having the hls sent back to the company for further investigation.Therefor i am requesting that a bio-kit be sent directly to ohsu, with attention to anna hansen and the ecls department.It was reported to me that this patient did not survive.They passed away at approximately 1300 on (b)(6).¿ complaint id# (b)(4).

Manufacturer Narrative

It was reported that a large amount of air entered the venous line from an unknown source.Once the centrifugal pump recognized an amount of venous air, it triggered an automatic pump stop.It was told that the ecls provider, who was assigned to the case was not able to resolve the venous air situation on his own, therefore the ecls coordinator was called down to help.Once he arrived the patient had been off support for longer than 6 minutes.It was noted that the air was removed from the venous line, and the circuit was again ready to be used in a proper manner.Unfortunately, the customer determined that to much time had passed from the time the patient went off support to the time the circuit was again ready for use.A decision was made from the customer to withdraw mechanical hls and cardiohelp support from the patient.Subsequently the patient expired.The customer was performing an autopsy.In the autopsy an underwater test on the hls module advanced was performed and they determined that the circuit didn't have any leaks or compromised integrity of any kind.A getinge field service technician (fst) did multiple attempts to the customer.The customer confirmed that he performed an own internal investigation and found out that neither the hospital staff nor the devices have led to the event.Therefore the customer did not send the hls set back for investigation.The affected cardiohelp was investigated in complaint# (b)(4) (mfg report number 8010762-2022-00494).A fst was sent for investigation on 2022-12-05 for the cardiohelp device.No malfunction of the device was found therefore no part was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A medical review was performed on (b)(6) 2023 by getinge medical affairs with following conclusion: "the evaluation of the described event resulted in the conclusion that the cardiohelp and the hls set that where uses both worked as expected.The customer stated after performed testing and autopsy that no evidence was found to implicate the hls module or the cardiohelp as a potential cause for the event.The root cause of the air entrancement remains unclear.Most likely possibilities of air entrancement would be the following.Venous cannula dislocated or disconnected from the circuit.Air inside the venous system of the patient that was entrained into the pump" the production records of hls set were reviewed on 2023-02-09.According to the final test results the hls set passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "air in venous line" could be confirmed, but was not related to a device malfunction.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2021-12-05 till 2022-12-05).The customer will be informed about the results by the getinge sales and service unit.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.H3 other text : customer did his own investigation and excluded the hls set as a cause.

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: 15937597
• MDR Text Key: 305037984
• Report Number: 8010762-2022-00489
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female