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

Model Number BEQ-HLS 7050

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Respiratory Failure (2484)

Event Date 04/02/2022

Event Type  Death  

Event Description

It was reported that the customer had difficulties getting adequate flow despite being able to flush the cannulas.The surgeon placed a 15 fr dlvv crescent in the rijv percutaneously.No fluouro for cannulation.Echo at bedside.Circuit was attached to the cannulas and rpms (rotations per minute) increased to 2000 and lpms (liters per minute) not able to increase higher than 350.Venous returns positive and membrane pressures 90s.Surgeon manipulated cannula with no change.Echo at bedside.Surgeon added a 15fr single lumen right femoral cannula and y¿d in with other cannula.Still not able to flow.Svo2 90s so we knew we were just recirculating.Both cannulas when unclamped had great blood return and able to flush.Patient began to code once unable to flow adequately on ecmo.Compressions were started and meds given.Cardiohelp disposable removed from centrifugal head and placed on hand crank.Primer hand cranked to the max to try to get flow with difficulty.Picu team called the code.Parents requested that cannulas be removed so they could hold their son.We examined both cannulas for clots or obstructions.A chunk of what appeared to be tissue was removed from a few holes on the cannula.No clots or other obstructions seen.The patient passed at 6:45am on (b)(6) 2022 and official cause of death is respiratory failure.The reason he was placed on ecmo was because of respiratory failure.Complaint id: (b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported event occurred in usa.The following complaint information was provided to maquet cardiopulmonary: " had difficulty getting adequate flow despite being able to flush the cannulas.Circuit was attached to the cannulas and rpms increased to 2000 and lpms not able to increase higher than 350.We examined both cannulas for clots or obstructions.A chunk of what appeared to be tissue was removed from a few holes on the cannula.No clots or other obstructions seen.The patient expired." the returned product was technically investigated at the laboratory of the manufacturer.The first visual inspection of the hls module did not detect any damage, such as cracks, fractures, deformations, etc., or any other abnormalities.On subsequent inspection of the entire system, no clots, tissue residue or other foreign bodies were detected.Flow test: during the flow test in accordance with the procedure defined in the test plan, no abnormalities were observed.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 did not had an influence on the function of the centrifugal pump.Functional test: the additional performed functional test with water over one hour shows constant flow over the complete testing period without deviations.Based on the tests performed (flow test & functional test) it can be stated that the function of the centrifugal pump of the complaint hls module advanced is given.Sensor test: during the subsequent pressure test, plausible pressure values could be read out over 30 minutes.An increase in temperature of 10°c did not have a negative influence on the pressure measurement or the pressure values.Pressure as well as temperature values could always be measured during the entire course of the test.Based on the tests performed it can be stated that the function of the entire sensor system of the complaint hls module is given.Based on this the reported failure "no adequate flow" was not confirmed during technical investigation of the product.The reported failure was technically not reproducible.The production records of the affected hls module (batch 3000159545, 3000163088, 3000157917) were reviewed.Following tests are performed as a 100 % inspection: bioline coating.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)(4) passed the test as per specifications.Production related influences are unlikely to have contributed to the reported failure.Additionally a medical review of the event information was performed by medical affairs and the following was concluded: "after a detailed analysis of the available data and extensive investigations of the cardiohelp system (hardware), no malfunctions, defects, or deficiencies in performance of the product could be identified.The cardiohelp and its sensors were thoroughly checked by the getinge service technician.The conclusion of the report was that the device performed according to expectations.Patient related root causes of the inability to achieve patient flow may have been related to any or all of the following: -recirculation of blood between the ports of the dual lumen internal jugular cannula the complaint narrative explains that the venous saturation was 99%.This is suggestive of possible recirculation between the inlet and outlet of the dual lumen internal jugular cannula.Hypovolemic shock.Hypovolemic shock (hs) has been shown to be associated with decreased peripheral perfusion.The low middle (mean) arterial pressures (stated as between 42 mmhg and 57 mmhg) may be indicative of hypovolemic shock.Hypovolemia (relative) that is commonly associated with hs is directly related to loss of vascular volume.The complaint narrative states that several fluid additions (viz.Packed red blood cells and saline) were made during the course of treatment.Additionally, the complaint narrative explained that a ¿chunk¿ of tissue was identified in the cannula upon removal from the patient.This observation may be indicative of structural perforation, which may have led to intravascular volume loss.Consequently, a significant loss of blood volume (regardless of etiology) may have led to an inability to achieve adequate blood flow.Cannula obstruction or malposition: as mentioned in the previous point, the narrative explained that a ¿chunk¿ of tissue was identified in the cannula upon removal from the patient.Depending on size, the ¿chunk¿ of tissue may have served to obstruct an opening in the cannula, thereby, reducing preload flow by 50% (or greater) depending on the location of the obstruction.Further, the narrative explains that the cannula was repositioned several times.Malposition of the cannula may also serve to inhibit adequate flow through a cannula and, hence, through the extracorporeal circuit.The clinician involved in the event seemed to have this in mind from the ostensible attempts at repositioning the cannula as well as seeking a third cannulation site.Given the results of the getinge investigation performed on the hls set advanced disposable, it is challenging to assign a structural malfunction or diminution in performance to the product.Last, upon examination of the available information as well as the investigation of the product itself, the expiration of the patient does not appear to be related to the performance of the product." thus the reported failure "no adequate flow" was not confirmed during investigation and was most probable not caused by a product related malfunction.The exact root cause of the reported event could not be determined.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: 14042297
• MDR Text Key: 288785906
• Report Number: 3008355164-2022-00009
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2022
• Device Model Number: BEQ-HLS 7050
• Device Catalogue Number: 701052794
• Device Lot Number: 3000163088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2022
• Distributor Facility Aware Date: 06/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2022
• Date Manufacturer Received: 06/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 20 MO
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 12 KG