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

Model Number HQV 128702#PACK VKMO 71000

Device Problem Output Problem (3005)

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

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description sent by the perfusionist: "the failure occurred 100 minutes after cec, when we were finished and we were going to start the pump output, so there has been no problem with the patient, since we left quickly, and the patient has woken up and evolved without problems today.Male, (b)(6) years old, weight (b)(6), size 1.67cm, bsa 1.99m2.It was at a pump flow of 3800, with 32 degrees of temperature, with a flow of gases of 1.2 and a fio2 of 50% and the gasometry was: ph7.32, po2 156, pco2 42, and so2 98.7%.Suddenly the blood became very dark and i took out others, having previously risen, the gas flow to 3l and the fio2 to 60%, and the result was: ph 7.26, po2 51.7, pco2 53.3, so2 84.4%.I went back up to fio2 of 100% and 4l and i left cec." complaint: (b)(4).

Manufacturer Narrative

It was reported that after approximately 100 minutes of use, at the end of the operation, the blood coming out of the oxygenator was dark and the partial oxygen pressure decreased.The product has been investigated in the laboratory of manufacturer on 2021-03-29.The visual inspection showed that the product was delivered pre-cleaned.The tightness of the gas side, blood side and water side were performed and no abnormality was found.The leak test performed on blood side and water side also showed no abnormalities.Based on the test results, there is no indication of a cause for poor oxygenation.Since the product is pre-cleaned, clot formation could not be verified by the laboratory of manufacturer.Medical assessment has been performed on (b)(6) 2021 by medical affairs.Taking the investigation report and the customer details in consideration, no root cause of the observation by the customer (low saturation and oxygenation) could be reasonably determined.Additionally, the event cannot be attributed to the product from with the details that are currently available.The possible root causes of the low oxygenation may be any, none, or all (in combination) of the following: -unknown/unvisualized clotting present in the oxygenator; -unknown clotting in the patient that was transferred to the oxygenator (e.G.Venous embolism) and bypass circuit, but unrecognized by the user.; -an unrecognized hypermetabolic state present in the patient; -an under-anesthetized patient which allowed for increased oxygen consumption.With reference to the risk assessment (quadrox-i small adult/adult, quadrox-id, dms #1464420 v17 ) the following events can contribute to clotting in the circuit: -blockage of oxygenator; -obstruction of filter; -blockage of blood flow; -inappropriate blood flow; -air, particles, thrombogenicity in the circuit.At this point, the exact root cause of the event contained in this complaint is not able to be determined with a fair degree of accuracy without more details from the customer.Based on this the reported failure could be confirmed.Device history record was reviewed on 2021-02-16.There were no references found, which are indicating a non-conformance of the product in question.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: 11284121
• MDR Text Key: 242862241
• Report Number: 8010762-2021-00098
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: HQV 128702#PACK VKMO 71000
• Device Catalogue Number: 70107.4266
• Device Lot Number: 92297607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Date Manufacturer Received: 04/01/2021
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 90