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

Model Number BEQ-HMOD70000-USA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is still pending.

Event Description

After initiating ecls (extra corporal life support), customer noticed a leak in the arterial outlet of the oxygenator.It became more noticeable upon attempting to move the patient.Oxygenator was changed out and there was no negative patient impact.The product is available for investigation and will be returned to the manufacturer.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that after initiating extracorporal live support, the customer noticed a leak in the arterial outlet of the oxygenator.It became more noticeable upon attempting to move the patient.The oxygenator was changed out and there was no negative patient impact.The product was returned to the manufacturer for technical investigation.During visual inspection blood was detected under the thread of the blood outlet connector.During a tightness test a leakage at the arterial blood outlet connector was confirmed.Upon further investigation it was confirmed that the glue used at the screwed blood outlet connector was applied unevenly.Thus the reported failure "leak in the arterial outlet of oxygenator" could be confirmed and was caused by an uneven applied glue at the thread connection of the connector to the oxygenator housing which led to a blood leakage as the connection was not proper sealed.Mcp production was informed about this observation on 2021-05-19.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.

Event Description

Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The root cause was determined as an unevenly applied glue at the thread connection of the connector to the oxygenator housing.As an action the maquet cardiopulmonary gmbh production was informed on 2021-05-19 of the investigation results and the employees were retrained for production step "glue application and harden of connectors" as per the training records.During the trend review no additional complaint for the failure "leakage at the blood outlet connection" has been found within the last 12 months.Therefore, this has been considered a single event.No further actions are necessary at this time.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
• MDR Report Key: 11453408
• MDR Text Key: 239749980
• Report Number: 8010762-2021-00172
• 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: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2022
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 70106.7859
• Device Lot Number: 70140852
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 05/06/2021; 06/02/2021
• Supplement Dates FDA Received: 05/20/2021; 06/15/2021
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 91