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

Model Number BE-HLS 5050

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that in the first two hours after installing the hls set 7.0 the patient had difficulty in arterial saturation.Two blood samples were collected from the pre-membrane portion and it was found that the po2 (post-membrane) did not rise more than 100, and the patient had an svo2 of 64.Blender tests were performed (gas mixer) and connecting an o2 cylinder (100%) still did not increase saturation.The patient presents with hyperdynamism with a cardiac output of 8l.However, after a few hours the patient is stable and with a sao2 of 85% with ecmo blood flow of 5.5lpm.Although there is a suspicion of oxygenator failure, clinical investigations are still being carried out, as the product has not been changed so far, and the patient remains stable.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The following complaint information was provided to maquet cardiopulmonary: "in the first two hours after installing the hls set 7.0 (lot 3000171262) the patient had difficulty in arterial saturation.Two blood samples were collected from the pre-membrane portion and it was found that the po2 (post-membrane) did not rise more than 100, and the patient had an svo2 of 64.Blender tests were performed (gas mixer) and connecting an o2 cylinder (100%) still did not increase saturation.The patient presents with hyperdynamism with a cardiac output of 8l.However, after a few hours the patient is stable and with a sao2 of 85% with ecmo blood flow of 5.5lpm.They were using a blender bought locally, and it was perceived as not accurate fio2 regulation, after changing they could figure out a better fio2 by using an o2 sensor to test the gas line.The affected product was discarded by the customer and therefore not available for technical laboratory investigation of the manufacturer.Thus it was not possible to determine the exact root cause of the reported event.The production records of the affected hls set (batch 3000179512, 3000171262, 3000166420, 3000166419, 3000171263, 3000162912) were reviewed on 2022-06-07.Following tests are performed as a 100 % inspection: leak test after welding.Pressure test heat exchanger.Leak test water side.Leak and flow test gas side.Pressure test blood side.Coating test.According to the final test results, all oxygenators passed the test as per specifications.Production related influences are unlikely to have contributed to the reported failure.A medical assessment of the provided event description was performed by medical affairs and the following conclusion was provided: after evaluating the available information, it appears that the oxygenator was functioning as expected.The customer stated that the pressure difference of the oxygenator membrane (delta pressure) was 25 mmhg.While a delta pressure of 25 mmhg is lower than expected for a flow of approximately 5 lpm, a lower than expected delta pressure is not indicative of a membrane obstruction or a decrease membrane surface area, e.G.Due clotting within the membrane.The expectation in either scenario (i.E.Membrane obstruction or a decrease membrane surface area) is an elevated delta pressure for any given target flow.Furthermore, it was mentioned by the customer that no sign of ¿coagulation or clogging¿ was observed or detected.The complaint narrative also indicated that after replacement of the gas blender with a known calibrated gas blender, the pao2 increased from 82 mmhg to 180 mmhg without exchanging the oxygenator.The rapid response (increase) in po2 with the exchange of the gas blender strengthens the assumption that the oxygenator was performing as expected.This suggests the culprit (root cause) may have been a faulty gas blender (as implied by the complaint narrative).Because of a severe dysregulation of the patient to infection, septic shock may induce a profound imbalance between oxygen consumption and delivery.A sepsis-derived dysregulation between oxygen consumption and delivery may explain the inability to achieve customary and expected po2s (viz.Higher than expected o2 consumption relative to o2 delivery).Because of patients in septic shock require high do2s (oxygen delivery) rates to maintain anaerobic metabolism, it is usually essential that do2s correspond to the increased rate of o2 consumption customarily observed in refractory sepsis.Little evidence is available to suggest the performance of the hls set advanced 7.0 was either compromised or diminished, especially when a replacement gas blender was used which resulted in an apparent rapid elevation of the patient po2 and signals membrane responsiveness.The complaint report mentioned that the expiration of the patient was the result of refractory septic shock; therefore, a diminution of performance would be difficult to assign to the product in context of this complaint.Based on this the reported failure "difficulty in arterial saturation" could not confirmed and was most probable not attributed by a product related malfunction.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 : 4115.

• 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: 13950831
• MDR Text Key: 288271428
• Report Number: 8010762-2022-00104
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Model Number: BE-HLS 5050
• Device Catalogue Number: 701069076
• Device Lot Number: 3000179512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female