MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

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

Device Problem Decrease in Pressure (1490)

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

Event Date 07/01/2023

Event Type  malfunction  

Event Description

The event occurred in the us.It was reported that a high delta pressure (60-80 mmhg) was noticed in the hls module during treatment.After an hour it raised to 100 mmhg and the flow to the patient dropped.The affected hls set is already scrapped by the customer.The set was successful exchanged with no consequences for the patient.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that a high delta pressure (60-80 mmhg) was noticed in the hls module during treatment.After an hour it raised to 100 mmhg and the flow to the patient dropped.The affected hls set is already scrapped by the customer.The set was successful exchanged with no consequences for the patient.No harm to any person has been reported.The affected product is not available for technical investigation, as it was discarded by the customer.Therefore the root cause remains unknown.However, according to the risk assessment of the hls set advanced 5.0 / hls set advanced 7.0 (dms # 1468452, v26) the following root causes can lead to the reported failure: deteriorating gas transfer.Blockage of oxygenator.Damage of gas fibers.Malfunction of oxygenator.Too low anticoagulation.Too low at level, effect of heparin is too limited.Protamine sulfate enters the hls set.Thrombocytopenia.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 7.0 g-660 version 04 · us.Chapter 4.2 safety instructions for the extracorporeal circulation 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.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.The production records of affected beq-015703112 #shls module advanced adult was reviewed on 2023-08-31 and according to the final test results, the beq-015703112 #shls module advanced adult with serial number 1862703 passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "high delta p and pressure drop" 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 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.H3 other text : 4115.

• Brand Name: HLS SET ADVANCED 7.0
• 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: 17286333
• MDR Text Key: 318648741
• Report Number: 8010762-2023-00332
• 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: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000298130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention