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

Model Number BE-HLS 7050#NON-CE SHLS SET ADVANCED 7.0

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 07/03/2023

Event Type  malfunction  

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

The event occurred in japan.It was reported that a 3-way stopcock was connected on the quick vent luer lock port of the hls module and a leak was noticed which made the priming impossible.The port was broken on the root.Another set was priming an the ecmo procedure started with a delay of 5-10 minutes with no consequences for the patient.No ham to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

In section h the type of reportable event has been filled out as "serious injury" by mistake.The type of reportable event has been corrected to "malfunction".

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a 3-way stopcock was connected on the quick vent luer lock port of the hls module and a leak was noticed, which made the priming impossible.The port was broken on the root.The failure occurred during priming.Another set was primed an the ecmo procedure started with a delay of 5-10 minutes with no consequences for the patient.The device caused the complaint and was not able to work as per factory¿s specifications.The affected product was investigated visually in the getinge laboratory on 2024-02-01 and the reported failure could be confirmed.An exact root cause for the broken connector remains unknown.However, according to the hls set risk assessment following root cause can lead to the reported failure: - mechanical damage to the connector during connection - mechanical damage to the connector due to high tensile force and mechanical hit.As stated in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 - in chapter preparation and installation ¿perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fissures.¿ furthermore, it is stated in chapter priming the system ¿check the device for leaks during priming.Do not use the device if there are any leaks.¿ and ¿before priming the set, run water through the heat exchanger of the hls module advanced and check for leaks.¿ the production records of the affected product were reviewed on 2023-12-05 for the reported failure.According to the final test results, the affected product 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 "leakage on luer lock and port damaged" could 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.

Event Description

Complaint# (b)(4).

• 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: 17267128
• MDR Text Key: 318480767
• Report Number: 8010762-2023-00327
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#NON-CE SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701077943
• Device Lot Number: 3000307915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose