MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PVS 2338#

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported when using an hls cannula, the handle of the introducer came off when the introducer was pulled out of the cannula.It was noticed when withdrawing the introducer from the cannula during patient use.The product was used in patients.No new cannulas were used.The patient was not affected when the introducer was withdrawn from the cannula.No harm to any person was reported.The photograph provided by the customer shows the handle separated from the introducer.The glue residues on the introducer could be seen from the photograph.The failure is confirmed.The production history record (dhr) of the affected be-pvs 2338# with lot # 3000190188 was reviewed.According to the dhr results, the product be-pvs 2338# passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Further the incoming inspection report of the affected component griff (batch # 3000178611) was reviewed.The griff was checked visually for pressure marks, rills, streaks, sinks, cords, bubbles, scratches, burrs, and also measured for diameter (inner).There is nc (b)(6) was opened for scratches inside of griff.However, this nc was canceled because it was opened by mistake.The product was produced by the supplier with new insert.Based on this, it could be concluded all tests were passed as per specifications.Further incoming inspection reports of the affected component introducer (batch # 3000163621 and 3000163623) were reviewed.The introducer was checked visually for ridges, sharp edges, cracks, streaks, bubbles and also measured for diameter (outer).All tests were passed as per specifications.The review of the non-conformities has been performed.It does not show any non-conformity in regards to the batch numbers of reported components and failure.The reported failure was identified as part of the current risk management file (hls cannulae) and the most probable causes are associated to: manufacturing: inappropriate assembly of components.Logistics: mechanical damage of product due to vibration and impact during transport and storage.Loosening of handle from introducer due to vibration and impact during transport and storage.User: loosening of handle from introducer during insertion of introducer into cannula due to mechanical loads.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

When using an hls cannula, the handle of the introducer came off when the introducer was pulled out of the cannula.Noticed when withdrawing the introducer from the cannula during patient use.Used in patients.No new cannulas were used.The patient was not affected when the introducer was withdrawn from the cannula.Complaint #: (b)(4).

• Brand Name: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 17305290
• MDR Text Key: 319109985
• Report Number: 8010762-2023-00340
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2023

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: 09/02/2023
• Device Model Number: BE-PVS 2338#
• Device Catalogue Number: 701047292
• Device Lot Number: 3000190188
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1