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

Model Number QUADROX-I SMALL ADULT/ADULT

Device Problem Infusion or Flow Problem (2964)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted when further information becomes available.

Event Description

"hello everybody, (b)(6) complained about an oxy from a set hqv 14607 and sent it to us.Lot from the set: 92294466 enclosed the perfusion protocol and pictures of the oxy.The oxy "closed" during the operation." according to complaint report: customer (b)(6) complained about an oxygenator from a set hqv 14607 and sent it to us.The oxygenator "closed" during the operation.

Manufacturer Narrative

It was reported that the delta p at the oxygenator slowly rises between 80-90 mmhg after about 30 minutes.The product has to be changed by 280 mmhg at delta p.Ecc of the patient successfully completed with the second product.The product was received by getinge laboratory for investigation and was investigated on 2021-02-24.The visual inspection of the oxygenator showed no abnormalities or damages.No clots were found during cleaning.The tightness test on the blood side and water side were performed and showed no leaks.The tightness test on the water side did not result in a pressure drop.Product passed the tests in the laboratory.The failure is not reproducible.No product problem could be detected.Based on the investigation the oxygenator is found tight therefore the reported failure increasing delta p could not be confirmed.However the failure mode blockage of oxygenator & increasing pressure drop can be linked to the following most possible root causes according to risk management file of the product quadrox-i adult dms #1464420 v17.Blockage of oxygenator / increasing pressure drop / impaired blood flow / deteriorating gas transfer: lack of information on pressure drop /pressure increase - user device history record for lot 92294466 of hqv 14607 and for lot 70136201 (serial (b)(6) of oxygenator were reviewed on 2021-01-25.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.The occurrence rate was calculated for the reported failure and product 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: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11213807
• MDR Text Key: 228218849
• Report Number: 8010762-2021-00021
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2022
• Device Model Number: QUADROX-I SMALL ADULT/ADULT
• Device Catalogue Number: 70107.0061
• Device Lot Number: 92294466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 02/24/2021
• Patient Sequence Number: 1