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 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the extracorporeal circulation, the oxygenating module did not exchange properly.After 1h of extracorporeal circulation, the internal dp was> 150mmhg, so the staff decided to replace the oxygenator with a new unit.Complaint #: (b)(4).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that 01971110 #squadrox-i + filtereinheit did not oxygenate properly and after 1h of extracorporeal circulation, the internal dp was> 150mmhg.The product was changed and the new product was performing well.The sample was received for investigation.During visual check no abnormalities or damages were detected.A leak test for the blood side and for the water side were performed.The leak test on the blood side showed a pressure drop of approximately p = 1.1 bar after 360 minutes.A leak was found at the gas outlet.The test on the water side did not result in a pressure drop.No leak was detected on the water side.Thus the failure "increasing dp" could be confirmed.Device history record for lot 92280682 and for lot 70136225 (serial number (b)(6)) of oxygenator were reviewed.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.Risk review has been performed on 2021-02-24.The failure is covered by the risk assessment of the quadrox-i small adult/adult, quadrox-id adult (dms #1464420 v17) in risk ids r1.3.1.2 (hypoxemia), r5.1.9.14 (adverse health consequences), r5.1.23.1 (air embolism), r9.4.3.1 (embolism).Since no further information could be provided by customer regarding cooling of patient, anticoagulation management, regular measurements, flow / pressure curves, ultrafiltration or haemoconcentration during the surgery no exact root cause could be determined.The customer suspects that the patient has a coagulation disorder because customer experienced same problem for the other company's two ultrafiltration circuit.However based on the investigation results and in reference to our risk management file of the product quadrox adult the most probable root cause is associated with -lack of information on occlude or blockage the gas outlet damage of gas fibers -lack of special operating instructions and blockage of oxygenator due to lack of information on pressure drop / pressure increase.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.

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11013427
• MDR Text Key: 222843414
• Report Number: 8010762-2020-00439
• 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: 03/08/2021

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: 02/18/2022
• Device Model Number: QUADROX-I SMALL ADULT/ADULT
• Device Catalogue Number: 70104.2436
• Device Lot Number: 92280682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/08/2021
• Patient Sequence Number: 1