MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID SMALL ADULT/ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA

Device Problem Infusion or Flow Problem (2964)

Patient Problem Air Embolism (1697)

Event Date 08/05/2021

Event Type  Death  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that a patient was on vv ecls (veno venous extracorporeal life support) since (b)(6) 2021 for covid.They had received 4 oxy changeouts during the run of which, the last(this oxygenator) was done morning of the death of the patient.On the afternoon of (b)(6), the patient was clamped out due to hemodynamic instability seeming to stem from right heart failure.There was massive air found in the hepatic veins and ivc (vena cava inferior).There were no issues with the changeout and there was never any air seen in the circuit and the rotaflow bubble alarm never went off.The customer was able to flow between 5 and 6 lpm (liter per minute) consistently between the changeout and when he clamped out.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a patient was on vv ecls (veno venous extracorporeal life support) since (b)(6) 2021 for covid.They had received 4 oxy changeouts during the run of which, the last(this oxygenator) was done morning of the death of the patient.On the afternoon of (b)(6), the patient was clamped out due to hemodynamic instability seeming to stem from right heart failure.There was massive air found in the hepatic veins and ivc (vena cava inferior).There were no issues with the changeout and there was never any air seen in the circuit and the rotaflow bubble alarm never went off.The customer was able to flow between 5 and 6 lpm (liter per minute) consistently between the changeout and when he clamped out.The affected product was investigated at the laboratory of the manufacturer according to the following: - a visual inspection, especially for cracks / fractures was performed; no abnormalities were detected.-the product was prepared, filled with fluid and de-aired according to the priming procedure; no abnormalities were detected.-the gas side of the product was tested with a pressure of 22, 5mbar by 3 test cycles; no abnormalities were detected.-the blood side of the product was tested for leakages; no abnormalities were detected.-the water side of the product was tested for leakages; no abnormalities were detected.In summary it was during investigation concluded that no leakages, cracks or fractures were detected at the product which could have led to an air entry.The abnormality seen was a deformed blood outlet connector.Marks at the blood outlet connector, most probable caused by a forceps, were detected.Time and origin of these marks at the customer are unknown.This was most likely caused by clinical staff either before or after use.During technical investigation it was not possible to reproduce the reported failure "massive air entry".In relation to the oxygenator function, no technical cause could be determined.Thus the exact root cause of the reported event is unknown.The production records of the affected oxygenator were reviewed.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.The customer was contacted for additional information in relation to the reported event, but no additional information was provided to mcp despite several attempts.A medical review of the available event information was performed by medical experts of mcp with the following outcome: "an investigation of the product does not seem to point to a product related cause.Exogenous entrainment of air into the extracorporeal circuit may explain the presence of air in the ivc and the hepatic veins and may point to a root cause." it was concluded that the exogenous entrainment of air could have been caused by a broncho venous fistual or massive air entrainment via a central line that is opened (or disconnected) accidently.As the customer did not share any additional requested information on the reported event in reference to the medical review, especially on when and how the massive air was detected, it was impossible to conclude which scenario did happen exactly.Based on the investigation results most probable no product related malfunction did have contributed to the reported event.Thus the reported failure "massive air entry" could not be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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: QUADROX-ID SMALL ADULT/ADULT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12395175
• MDR Text Key: 269034468
• Report Number: 3008355164-2021-00022
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 701067859
• Device Lot Number: 3000163294
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2021
• Distributor Facility Aware Date: 09/28/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2021
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death