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

Model Number HLS SET

Device Problems Gas/Air Leak (2946); Infusion or Flow Problem (2964)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

It was reported that there where bubbles in the circuit on the venous line.The event occurred during treatment and 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 air bubbles in the hls set on the venous line, in the hls module and the centrifugal pump were noticed during treatment.The hls set was changed out with another one with no consequences for the patient.The failure occurred during treatment.The affected product was investigated in the getinge laboratory on 2024-03-18 with following conclusion: the reported failure could not be confirmed.During visual inspection foreign components were found on the hls module.The affected product functioned as expected.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.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 "air bubbles in the venous line" 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: 18579820
• MDR Text Key: 333730807
• Report Number: 8010762-2024-00048
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: HLS SET
• Device Catalogue Number: 701069073
• Device Lot Number: 3000319775
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1