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

Model Number HLS SET

Device Problem Pumping Stopped (1503)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.H3 other text : device already discarded by customer.

Event Description

It was reported that the pump stopped and no longer turned.The failure occurred during treatment.The cardiohelp device (complaint# (b)(4) was checked and had no issues.The hls set and the cardiohelp device were exchanged to a pls set and rotaflow.The getinge service technician suspects that the hls set was the issue of the problem, but was not able to check it, as the affected hls set was discarded by the customer.No harm to any person has been reported.Complaint id (b)(4).

Manufacturer Narrative

It was reported that the pump stopped and no longer turned.The cardiohelp device was checked and had no issues.The hls set and the cardiohelp device were exchanged to a pls set and rotaflow.The getinge service technician suspects that the hls set was the issue of the problem, but was not able to check it, as the affected hls set was discarded by the customer.The affected cardiohelp will be investigated in complaint# (b)(4) (mfg report number 8010762-2024-00026).The hls set affected product is not available for technical investigation as it was discarded by the customer.Therefore the exact root cause remains unknown.However, according to the hls set risk assessment following root cause can lead to the reported failure: - static load of the oxygenator - loosening/dis-mantling of the pump - blockage of oxygenator according to the instruction of use of the hls set (chapter "preparation and installation") it is stated to perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fissures.Referring to chapter "safety instructions for centrifugal pump" it is stated that to listen for scratching noises when priming the system and to replace the hls set advanced if there are scratching noises.Further in chapter "priming the system" the speed function will be checked prior to connect to a patient.Based on the results the reported failure "pump stop as the device no longer turned" 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: 18509983
• MDR Text Key: 333472634
• Report Number: 8010762-2024-00022
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1