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

Model Number BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0

Device Problem Improper Chemical Reaction (2952)

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

Further patient and perfusion data was requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported low po2 measurements post oxygenator.The hls set was exchanged with another one.Same issue occurred again (reported under emdr#(b)(4), complaint#(b)(4) and the oxygenator was changed with an quadrox-id.No harm to patient reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the po2 (partial oxygen pressure) was low during treatment.The hls set was exchanged with another one which also failed quickly (complaint#(b)(4), mfg report#8010762-2021-00580).As confirmed by the sales and service unit the hls set was discarded by the customer.The patient was infected with covid-19.As stated by the getinge medical affairs team and in reference to available literature [1] covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.The increased risk of thrombosis and coagulopathy in ecmo patients may be the result of a combination of processes driven by covid-19 occurring in synergy with the known effect(s) of the extracorporeal circuit on the coagulation system.In the absence of data and based on covid-19 as the most probable root cause for the reported failure, clot formation in an extracorporeal circuit can lead to a reduction and/or blockage, and thus, an reduction of the diffusion path lowering the gas transfer performance.With reference to the risk assessment and in consultation with the getinge manager medical affairs team the following events can contribute to clotting in the circuit: -air remains in or enters the circuit (not for long run incidents); - inappropriately low, or no blood flow, in the circuit; -improper hemostasis; -too low anticoagulation; -too low act level, effect of heparin is too limited; -protamine sulfate enters the hls set; -administration of congealable substances (such as platelets) or pro-coagulant medications.-(consumption) coagulopathy.In addition it was stated that the second failing hls set was exchanged for a quadrox-id adult and no further issue was noted.This could also indicate that the hls set 5.0 was to small for sufficient oxygenation as already determined in the risk assessment.Based on the investigation results the reported failure "low oxygenation" could be confirmed.The occurrence rate was calculated for the reported failure 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.Reference: [1] yusuff h, zochios v, brodie d."thrombosis and coagulopathy in covid-19 patients requiring extracorporeal membrane oxygenation" asaio j.2020;66(8):844-846.Doi:10.1097/mat.0000000000001208.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: 12725425
• MDR Text Key: 282621034
• Report Number: 8010762-2021-00579
• 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: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0
• Device Catalogue Number: 701052797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1