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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA
Device Problem Failure to Deliver (2338)
Patient Problem Cardiac Arrest (1762)
Event Date 04/30/2022
Event Type  Death  
Event Description
It was reported that patient in cardiac arrest getting chest compressions from lucas device and on an impella pump.Team cannulated patient and tried to start cardiohelp/hls support.Cardiohelp was unable to establish flow, rpms were brought up to around 3000 with no measurable flow.Some blood was witnessed mixing with prime solution on venous line.Patient expired.The team then tested the pump by placing the venous line in a basin of water and were not able to establish flow.They also brought in a second cardiohelp hardware unit and were unable to establish flow.Complaint id: (b)(4).
 
Manufacturer Narrative
The investigation of the manufacturer is ongoing.
 
Manufacturer Narrative
It was reported that patient in cardiac arrest getting chest compressions from lucas device and on an impella pump.Team cannulated patient and tried to start cardiohelp/hls support.Cardiohelp was unable to establish flow, rpms were brought up to around 3000 with no measurable flow.Some blood was witnessed mixing with prime solution on venous line.Patient expired.The team then tested the pump by placing the venous line in a basin of water and were not able to establish flow.They also brought in a second cardiohelp hardware unit and were unable to establish flow.The returned product was technically investigated at the laboratory of the manufacturer with the following results: the complaint sample was inspected and visually checked after delivery.The condition of the sample was documented by pictures.The first visual inspection of the hls module did not detect any damage, such as cracks, fractures, deformations, etc., or any other abnormalities.In delivery condition, two sample lines and were attached to the hls module.One on the blood inlet side, the other one on the blood outlet side.On subsequent inspection of entire system - apart of fluid blood residues - no clots, tissue residue or other foreign bodies were detected.The inspection was performed before cleaning, in the state of delivery.Conclusion flow test: during the flow test in accordance with the procedure defined in the test plan, no abnormalities in flow and available pressure values were observed.The requested flow values could be set in sequence and also achieved without any problems.Conclusion pump functionality test : based on the performed investigation the following conclusion can be stated.The polarity check of the magnets do not show any deviation.The test shows the correct alternating arrangement of the magnets.The functionality of the centrifugal pump could be maintained over the entire speed range up to 5000 rpm/min.Over the entire speed range no abnormalities like noise, unusually flow or pressure values could be identified.It is possible to stop and restart the centrifugal pump without abnormalities.Repeated installation and removal of the hls module advanced on the drive of the cardiohelp does not have an influence on the function of the centrifugal pump.The additional performed functional test with water over one hour at 0,533 bar (400 mmhg) shows constant flow over the complete testing period without deviations.Note that the functional test with water was performed with heated water (35°c) without additional reduction of the tube diameter.The circuit trough the heating spiral does not require an additional throttle to maintain a pressure of 400 mmhg.Based on the performed tests it can be stated that the function of the centrifugal pump of the complaint hls module advanced is given.After completion of the investigation, the malfunction of the hls module mentioned by customer / user cannot be confirmed.The reported failure was technically not reproducible.The production records of the affected hls module (batch 3000148737, 3000148896, 3000144209,3000144186, dms#3128934) were reviewed.Following tests are performed as a 100 % inspection: bioline coating, glueing of sensors, mounting of flex conductor and pin, tightness check, flow check gas side, functionality test hls module (sensors and pump).According to the final test results, the oxygenator with the serial# (b)(6) passed the test as per specifications.Production related influences are unlikely to have contributed to the reported failure.The investigation of the manufacturer is still ongoing.
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
After completion of the investigation, the malfunction of the hls module mentioned by customer / user cannot be confirmed.The complaint description could not be reproduced from a technical point of view.In conclusion, the reported failure cannot be confirmed.Furthermore a medial review of the event information and the investigation results was performed with the following outcome: based on the performed tests by the life cycle engineering (lce) of getinge it appears that the centrifugal pump of the complaint hls module advanced is functional.After completion of the investigation, the malfunction of the hls module mentioned by customer could not be confirmed.Additionally, the complaint description could not be reproduced from a technical point of view in the course of the investigation.Possible root causes of the inability to achieve the desired flow may be the following: the inadvertent activation of backflow prevention on cardiohelp.It could have been the case that the cardiohelp detected a backflow caused by the lucas device.The cardiohelp then enters backflow prevention and creates a zero flow.The user can only increase the flow by first leaving backflow prevention.Competition of flow between the cannulae (and their positioning) and the impella device.If the reported pressures (venous pressure: -20 mmhg, internal and arterial pressure: 30 mmhg) were measured with running flow, not properly calibrated pressure sensors could have been the root cause for the unusual low display pressure values.The customer stated that the hls set (with cardiohelp) was pre-primed.If the cardiohelp is powered off after the initial pre-priming, the calibrated pressure values would be lost unless the pressures were recalibrated pre-support.Further, uncalibrated values may have led to misinterpretation of the actual scenario, e.G.Higher than usual venous pressure with a reasonable rpm during initiation.It is also possible that uncalibrated values may not have properly represented an activated backflow prevention.In conclusion, the details of the customer complaint cannot be confirmed by internal testing and investigation; however, it is unclear why the medical team was not able to create flow with the cardiohelp system.It is not possible to pinpoint the exact root cause of the flow problems.That said, it is extremely challenging to attribute an association between the event explained in the complaint narrative and the hls module advanced used (or the cardiohelp hardware).It is unclear whether the cpr performed on the patient was due to the apparent emergent nature of the support event, the possible influence of delayed support,or the confluence of both scenarios.Moreover, an assignment of product malperformance to the expiration of the patient is equally challenging, especially given the outcome of the product investigation.The customer will be informed via the ssu (sales and service unit) about the investigation results.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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).
 
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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
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MDR Report Key14336876
MDR Text Key291209739
Report Number3008355164-2022-00012
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBEQ-HLS 7050 USA
Device Catalogue Number701052794
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/21/2022
Distributor Facility Aware Date07/14/2022
Event Location Hospital
Date Report to Manufacturer07/21/2022
Date Manufacturer Received07/14/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
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