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

Model Number HLS SET

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that after 45 minutes of veno-arterial ecmo, a small blood leak was observed through the joint of the oxygenator housing on the side of it close to the arterial outlet.During priming of the set no liquid leak was observed.The hls set was exchanged.The failure occurred during treatment.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that after 45 minutes of veno-arterial ecmo, a small blood leak is observed through the joint of the oxygenator housing on the side of it close to the arterial outlet.During priming of the set no liquid leak was observed.The hls set was exchanged.On 2024-10-26 the information was received that the patient had a cardiac arrest before connected to the affected product.According to the customer the outcome of the patient was good, the hls set was changed for a new one as a prevention.The affected product was investigated in the getinge laboratory on 2024 (b)(6) with following conclusion: the failure could be confirmed.The root cause for the leakage is a damaged sample line.The production records of the affected product were reviewed on 2023-12-11.According to the final test results, the product passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "leakage due to damaged sample line" could be confirmed.This complaint was found in the database of customer complaints for the hls set as a single event (timeframe from 2022-10-25 till 2023-10-25).The customer will be informed about the results by the getinge sales and service unit.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 id# (b)(4).

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 18010045
• MDR Text Key: 326558030
• Report Number: 8010762-2023-00522
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: HLS SET
• Device Catalogue Number: 701069073
• Device Lot Number: 3000303593
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1