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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problems No Flow (2991); Noise, Audible (3273)

Patient Problem Cardiac Arrest (1762)

Event Date 02/28/2022

Event Type  Death  

Manufacturer Narrative

Return of the affected product and further patient and perfusion data were requested but are still pending.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer was reported that during priming the air could not be completely removed and unusual noise was noted.In addition no flow could be established.Another ecls circuit and device was used.Later the patient expired according to the customer due to a heart attack.(b)(4).

Manufacturer Narrative

The event occurred in belgium.It was reported that during priming the air could not be completely removed and unusual noise was noted.In addition no flow could be established.Another ecls circuit and device was used.Later the patient expired according to the customer due to a heart attack.The affected be-hls 7050 #shls set advanced 7.0 with lot#3000204671 technically investigated in the getinge laboratory on 2022-05-10.During the investigation a functional test of the integrated pump was performed and neither abnormalities nor unusual noises could be confirmed.No other abnormalities on the affected hls module were noticed.The reported failure and the application method described by the customer was evaluated by getinge medical affairs on 2022-05-10 with the following outcome: the nature of the complaint focuses on the cardiohelp system and its associated disposable (hls set advanced).The complaint narrative describes an experience where the perfusionist attempted to prime the hls system, but had difficulty priming due to air entrainment in the hls disposable.During priming of the hls circuit, the user encountered an air-lock which caused a stop in the pump flow, where no forward flow could be generated.When the centrifugal pump deprimed, a noise arose from the centrifugal pump.The actual noise was not described by the customer in the context of the complaint.It was only described as a ¿noise¿.Because of the priming challenges encountered by the user, the extracorporeal platform was changed from cardiohelp (with the hls set advanced) to unnamed platform.It was mentioned that the second platform deployed was another manufacturer; however, the manufacturer remained unspecified.It was stated in the complaint that the patient expired.However, the expiration of the patient was explained as unassociated with ecls or the rescue effort, but due to an overwhelming clinical comorbidity, viz.A ¿massive heart attack¿.The investigation of the product demonstrated the product to be in working order and without defect(s).Further, the description of the complaint could not be reproduced (from a technical point of view) in the course of the product investigation.Correspondently, the customer complaint could not be confirmed.Conclusion: when priming the hls set advanced, to prevent air entrainment into the circuit, it is essential to allow the circuit to passively prime before increasing the rpms (revolutions per minute) to the target of 3000 rpms.Increasing the rpms before the circuit has passively primed and the flow has stopped will allow air entrainment into the circuit.When the integrated pump fills with air, a similar ¿grinding¿ sound is elicited as was demonstrated in the video sent by the customer.The priming steps are described in the instructions for use (ifu) for the hls set advanced.[1] when the local getinge representative visited the account in response to this complaint (i.E.The day following the event), the representative inspected the circuit and found that both the circuit as well as the hls set advanced were functional.One possible root cause of the event may be malpositioning of the hls disposable on the cardiohelp drive.The service pool data suggests that the drive could not read the disposable at one point in the priming process.Repositioning the hls module would have addressed this particular error.It was stated in the complaint that the patient expired.However, the expiration of the patient was expressed as unassociated with ecls or the rescue effort, but due to an overwhelming comorbidity, viz.A ¿massive heart attack¿.It is assumed, by extension, that no attribution of culpability was assigned either to the cardiohelp or to the hls set advanced disposable.Therefore, the event described by the customer cannot be reasonably attributed to a deficiency, or malfunction, of the device and/or the associated disposable product.That said, it is assumed that the event likely originated outside the equipment/disposable product in the form of a use error.Based on the information available at this time the cause of the reported failure was determined to not be attributed to a device related malfunction.However, the failure mode "air could not be completely removed and unusual noise" can be linked to the following most possible root causes according to our risk management file: de-airing membrane closed during priming.Air cannot exit during priming.Air remains in system.Insufficient function of de-airing port.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.References: [1] instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0.G-360.Art no.70106.5490.

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: 13708300
• MDR Text Key: 286835109
• Report Number: 8010762-2022-00074
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000204671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Prefer Not To Disclose