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

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

Device Problem Infusion or Flow Problem (2964)

Patient Problem Cardiac Arrest (1762)

Event Date 11/17/2022

Event Type  Death  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Following was initially reported: ¿received call from customer that they attempted to place a patient on ecls support.They were unsuccessful after multiple attempts.They looped the two limbs (arterial and venous) together and were able to circulate the pump with flow but when they connected to the cannulas in the patient they could not flow.Customer wanted both hls disposable and hardware inspected.¿ on 2022-11-22 the information was received that the patient expired because the customer was unable to get the patient on support.The customer had no back up cardiohelp.The perfusionist attempted to hand crank via the e-drive (emergency drive) but was unable to provide flow.The technician stated that the cannula failure was highly suspected by the customer.The perfusionist was unable to flow every time the circuit was connected to the cannulas.The perfusionist looped the venous and arterial limbs together and was able to flow without any issues.They were also able to hand crank via the e-drive when the circuit was looped together.When they reconnected to the cannulas they were unable to flow again.The cardiohelp device will be investigated in the complaint# (b)(4).Complaint id# (b)(4).

Event Description

Complaint id#(b)(4).

Manufacturer Narrative

It was reported that the customer attempted to place a patient on the ecls support.They were unsuccessful after multiple attempts.The customer looped the two limbs (arterial and venous) together and was able to circulate the pump with flow but when they connected to the cannulas in the patient they could not flow.On (b)(6) 2022 the information was received that the patient expired because the customer was unable to get the patient on support.The customer had no back up cardiohelp.The perfusionist attempted to hand crank via the e-drive (emergency drive) but was unable to provide flow.The getinge field service technician stated that a cannula failure was highly suspected by the customer.The perfusionist was unable to flow every time the circuit was connected to the cannulas.The perfusionist looped the venous and arterial limbs together and was able to flow without any issues.They were also able to hand crank via the e-drive when the circuit was looped together.When they reconnected to the cannulas they were unable to flow again.There is no feedback from the customer from which company the cannulas were.The affected hls-set was investigated in the getinge laboratory on (b)(6) 2023.There were no visible damages on the product.During the test priming procedure a constant flow could be achieved.Therefore the failure could not be confirmed.Additionally, the getinge field service technician confirmed, that the affected cardiohelp device has no failure and is function correctly.The cardiohelp was investigated in complaint# (b)(4), mfg report number 8010762-2022-00468.Moreover, a medical review was performed on (b)(6) 2023 with following conclusion: "based on the information available, the following root causes for the problems in generating flow could be feasible.These possible root causes may apply fully, partially, or not at all ¿ the customer stated that the perfusion was tried to start 10 minutes after the cannulas were placed into the patient´s vessels.Additionally, the data show that the partial thromboplastin time (ptt) was 32 seconds at the time of event.¿the ptt is the time it takes for a patient´s blood to form a clot as measured in seconds.¿(1) ¿ptt is commonly used in clinical practice to monitor patient response to unfractionated heparin infusion, to target therapeutic anticoagulation, and as part of a "coagulation panel" to help elucidate causes of bleeding or clotting disorders.¿(1) ¿measured in seconds to clot formation, normal ptt can vary based on laboratory or institution; however, normal ptt is between 25 to 35.¿(1) in the case of ecmo therapy, the ptt should be 1.5 to 2.5 times the normal ptt (2) according to this information, it can be concluded that the above mentioned ptt of 32 seconds is within the normal range, but below the range that would be necessary to be achieve during ecmo applications and can therefore lead to clotting.This and the fact that the cannulas were in the vessel for 10 minutes without blood flow may have caused thrombus to form in the cannulas.¿ the clinician stated that 10000 iu of heparin was administered to the patient.Ascpr was in process at the time support (and cannulation) was attempted, it is possible that ineffective cpr may have influenced the distribution of heparin to the entire vascular system, allowing thrombus to form in the systemic vascular system.¿ excessive suction placed on the venous cannula to the vessel may also have prevented flow.The following are possible contributors to excessive suction applied to the venous system.1.A high rpm may result in the application of excessive negative pressure to the cannula as well as the structure where the cannula was positioned/terminated.There is no information available from customer regarding how high the rpm was set when attempting to generate flow.2.If the cannula were not placed properly in the vessel an excessive suction maybe applied to both the cannula as well the surrounding vascular structures.3.Low patient volume may cause an excessive suction to be applied to the cannula in the jugular vein.The answer to question 6 in chapter 1.6.5 describes that there were challenges with the cannulation of the groin which may have resulted in a hematoma in the left groin.Because the size of the hematoma was not divulged by the clinicians, it is possible that a substantially sized hematoma have led to a too low volume status of the patient and, as a consequence, to excessive suction of the cannula.The result may be no flow or the inability to create blood flow.Based on the aforementioned possible root causes in addition to the life cycle engineering reports, there is no indication that the hls set advanced 7.0 and/or the cardiohelp was the source of the inability to create blood flow.Rather, the possibility of clotting, suction of the venous catheter, or the incorrect placement of the arterial cannula are the most likely root causes of the event.The examinations of the cardiohelp and the hls set advanced 7.0 are in support of this determination as no malfunctions could be confirmed.The expiration of the patient appears to be due to reasons outside of either the cardiohelp or the hls set advanced 7.0." the production records of the affected hls set were reviewed on (b)(6) 2023.According to the final test results, the hls modul passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "no flow could be achieved" was neither related to the hls set nor to the cardiohelp device and could therefore not be confirmed.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.

• Brand Name: TUBING SET
• 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: 15866915
• MDR Text Key: 304325714
• Report Number: 3008355164-2022-00030
• 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: Distributor
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000229334
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2023
• Distributor Facility Aware Date: 01/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2023
• Date Manufacturer Received: 01/20/2023
• 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