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

Model Number HLS SET

Device Problem Crack (1135)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that support was initiated, and the customer immediately noticed air entrainment into the pump.A crack in the tubing of the venous line at the connection to the venous cell was found.The hls set was exchanged.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that support was initiated, and the customer immediately noticed air entrainment into the pump.The failure occurred during treatment.A crack in the tubing of the venous line at the connection to the venous cell was found.The hls set was exchanged.A technical investigation of the product could not be performed, as the affected product was discarded by the customer.Therefore the exact root cause for the crack remains unknown.However, according to the hls set risk assessment following root cause can lead to the reported failure: the user did not perceive or recognize how to handle the emergency priming line or was not able to handle the emergency priming line appropriately, therefore air entered the venous line of the hls set.Referring to the instructions of use of the hls set (chapter 4.1 basic safety instructions) it is stated to not use defective devices (example if device is damaged).In chapter 4.3 ¿safety instructions for the hls set¿ it is further mentioned to check the set if its complete and not defective.Based on the results the reported failure "air entrainment due to crack in tubing" 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 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.H3 other text : device already discarded by customer.

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: 18510163
• MDR Text Key: 333132946
• Report Number: 8010762-2024-00024
• 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: 02/15/2024

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
• Device Lot Number: 300034447
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1