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

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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

The affected oxygenator was requested for further investigation but not received yet.Therefore the investigation is pending.A follow up medwatch wil be submitted when new information becomes available.

Event Description

It was reported that blood was leaking from the bottom of the oxygenator.Complaint #(b)(4).

Manufacturer Narrative

It was reported that blood was leaking from the bottom (housing) of the oxygenator.The affected oxygenator was investigated in the getinge laboratory on 2021-06-10.The tightness test of the water and the blood side showed no abnormalities.No leakage could be detected.After drying the oxygenator again, the oxygenator was flowed through in another test setup for 28 hours.No leakage could be detected hereby.However, when some air pressure was applied to the gas side, it was observed that 4 drops of water were blown out of the gas outlet.The most probable root cause could be determined as a leakage between the blood and gas side.According to our risk management file (dms#(b)(4)) this can be caused by the following: -broken or distorted fibers the production records of the affected oxygenator (dms# (b)(4)) were reviewed on 2021-04-16.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Production related influences are unlikely.Based on these investigation results the reported failure "leakage" 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.

Event Description

Complaint (b)(4).

• Brand Name: QUADROX-ID
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11683945
• MDR Text Key: 246246902
• Report Number: 8010762-2021-00254
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: HMOD 70000-USA #SQUADROX-ID ADULT O.FILT
• Device Catalogue Number: 70106.7840
• Device Lot Number: 70140120
• Date Manufacturer Received: 06/10/2021
• Patient Sequence Number: 1