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

Model Number BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0

Device Problems Increase in Pressure (1491); Infusion or Flow Problem (2964); Pressure Problem (3012)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the pressure reading (delta p) climbed from 38 mmhg to 193 mmhg and also with corresponding dropping flows.The failure occurred during treatment and the hls set was exchanged.No harm to any person has been reported.Complaint id# (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the pressure reading (delta p) climbed from 38 mmhg to 193 mmhg and the flow was dropping.The failures occurred during treatment and the hls set was exchanged.After the exchangement of the hls set the pressures and the flow were stable.The device caused the complaint and was not able to work as per factory¿s specifications.The affected hls set was investigated by the getinge laboratory on 2023-03-24 with following conclusion: the failure of the high pressure reading could be replicated.The pressure readings were not function after a short time of testing and a leakage was found.Therefore, the most probable root cause is a leakage of the arterial pressure sensor, which lead to the pressure reading failure.The failure of the flow could not be reproduced.Constant and plausible flow rates were achieved during the flow test.According to the current risk assessment of the hls set advanced, hit set advanced the following root cause can lead to the reported flow failure: - blockage of oxygenator.The production records of the affected beq-hls 7050-ca #shls set advanced 7.0 were reviewed on 2023-03-28.According to the final test results the hls module passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "pressure reading failure" could be confirmed and the reported failure "flow issue" could not be confirmed.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.

• 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: 16101263
• MDR Text Key: 307668927
• Report Number: 8010762-2023-00006
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000259980
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1