MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number HQV 3300#QUADROX COMPLETE PACK

Device Problem Free or Unrestricted Flow (2945)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Product has been requested for investigation but not received yet.

Event Description

It was reported that the customer assembled the tubing pack onto the heart and lung bypass machine.When heparin was given the perfusionist noticed a lot of air in the quart arterial filter.The customer changed out the whole tubing set.The new circuit had no issues.Complaint: #(b)(4).

Manufacturer Narrative

The product was received and investigated in the laboratory on (b)(6) 2021.Visual inspection and priming according to instruction for use (ifu) were performed.During the visual inspection of the complaint sample, no damage or abnormalities could be found.The priming according to ifu was performed successfully.The flow test was applied to the product.The result of flow test shows that there is no pressure increase.The investigation results show, no technical deviations were found.The product did not show any abnormalities either during priming or during the flow test.The flow test was performed based on the maximum values given in the ifu ((b)(4)).The reported failure "air in the quart arterial filter, high pressure within the quart arterial line filter" could not be reproduced.Device history record for lot # 92306983 for tubing set was reviewed on (b)(6) 2021.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.Device history record for lot #: 70143016 for quart-arterial filter was reviewed on (b)(6) 2021.Following steps are performed according to the basic operation procedure (bop) with a 100 % inspection: check for mechanical damages; check for montage error; tightness test.According to the final test results, all quarts - arterial filters passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.However the failure mode "air" and "pressure too high" can be linked to the following most possible root causes according to our risk management file (dms # 1674197, v17): not open the integrated bypass in case any abnormal pressure increase; tube system not completely de-aired.The failure is not attributable to the device.The failure could not be confirmed by laboratory investigation.This case is an isolated event for the reviewed time period ((b)(6) 2021-(b)(6) 2020).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: TUBING SET
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11567204
• MDR Text Key: 242198222
• Report Number: 8010762-2021-00210
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: HQV 3300#QUADROX COMPLETE PACK
• Device Catalogue Number: 70100.4874
• Device Lot Number: 92306983
• Date Manufacturer Received: 06/07/2021
• Patient Sequence Number: 1