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).

• Brand Name: QUADROX-ID SMALL ADULT/ADULT
• 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: 12394552
• MDR Text Key: 269029141
• Report Number: 8010762-2021-00480
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101153
• 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: 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

• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 701067859
• Device Lot Number: 3000163294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/31/2021 Patient Sequence Number: 1