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 Device Alarm System (1012); Insufficient Information (3190)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the arterial flow bubble sensor is alarming intermittently.The tubing on the hls set was cleaned, the sensor was moved, and the alarm continued.After the flow bubble sensor was exchanged, the cardio help was also exchanged, and the issue did not solve.No air bubbles or clots were seen in the circuit at the time.The arterial/bubble intervention is not used by the customer.The hls set was exchanged due to coagulation reasons.The circuit was not available for return.No harm to any person has been reported.The failure occurred during treatment.Complaint id (b)(4).

Manufacturer Narrative

It was reported that the arterial flow bubble sensor is alarming intermittently.The tubing on the hls set was cleaned, the sensor was moved, and the alarm continued.After the flow bubble sensor was exchanged, the cardiohelp was also exchanged, and the issue did not solve.No air bubbles or clots were seen in the circuit at the time.The arterial/bubble intervention is not used by the customer.The hls set was exchanged due to coagulation reasons.The circuit was not available for return.The failure occurred during treatment.On 2024-02-28 it was confirmed that the cardiohelp has no malfunction and was only replaced for troubleshooting before exchanging the hls set.The exact root cause remains unknown, as the hls set was not available for return.However, according to the hls set risk assessment following root cause can lead to the reported failure: connection is too loose air infiltration into arterial line flow bubble sensor is attached into too distal position at the arterial line the flow bubble sensor was not installed close to the blood outlet of the hls module according to the instruction of use of the hls set it is mentioned that incorrect positioning of the cardiohelp can cause air permeation on the blood side of the hls module advanced.The cardiohelp must be positioned at a lever lower that the patient and secured close to the patient.The flow/bubble sensor must always be affixed on the arterial side of the set if you are using the cardiohelp-i.With an activated intervention, the detection of bubbles by the flow/bubble sensor triggers a pump stop.In addition, it is stated that ¿no anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.Weigh the benefits of extracorporeal circulation against the risk of systemic anticoagulation.Use anticoagulants; e.G.Heparin or argatroban.Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).Ensure that the act value does not fall below the value which is appropriate for the application.Check the coagulation status of the patient's blood regularly.The protocol for coagulation management is the responsibility of the user in charge¿.And ¿to prevent hemostasis during application, regularly check the hls module advanced for signs of coagulation¿.The production records of the affected product were reviewed on 2024-02-28.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 "flow/bubble sensor is alarming intermittently " 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.

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: 18854417
• MDR Text Key: 337073352
• Report Number: 8010762-2024-00121
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 3000328478
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 104 KG