MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID ADULT O.FILT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMOD 70000-USA #SQUADROX-ID ADULT O.FILT

Device Problem Improper Chemical Reaction (2952)

Patient Problem Low Oxygen Saturation (2477)

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 that the oxygenation of the quadrox-id was insufficient.Complaint id: (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

It was reported that the oxygenation performance of a quadrox-id was low during treatment.The quadrox-id was discarded by the customer, thus no technical investigation could be performed.However following probable root causes were already identified in the risk assessment quadrox-id adult: - specification of requirements for extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen and removal of carbon dioxide not met - insufficient flushing - leaks or damage to the oxygenator.Further it was stated that the patient was infected with covid-19.As stated by the getinge medical affairs team and in reference to available literature 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.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.Based on the investigation results the reported failure "low performance" could be confirmed.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.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.

• Brand Name: QUADROX-ID ADULT O.FILT
• 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: 12725422
• MDR Text Key: 279256159
• Report Number: 8010762-2021-00578
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150267
• 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: 02/17/2022

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: HMOD 70000-USA #SQUADROX-ID ADULT O.FILT
• Device Catalogue Number: 701067840
• Device Lot Number: 3000168944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1