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

Model Number BE-PVL 2355#

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that torn cap from the inducer felt down after connection to cannula.It was occurred during cannulation.The cannula was inserted into the patient with no patient harm.Complaint #: (b)(4).

Manufacturer Narrative

It was reported that torn cap from the inducer felt down after connection to cannulae.The cannulae was not used, inserted.No harm to any person was reported.The product was investigated in the laboratory of manufacturer on 2022-05-22.The griff was delivered away from the introducer with glue residues on both components.The production procedure states that 20mm of gluing area needs to be covered with primer and afterwards glue.From the images taken in the laboratory, there is a greater area free of residue visible, which lead probably to the connection weakness between introducer and handle.The reported failure can be confirmed.The production history record (dhr) of the affected be-pvl 2355# with lot # 3000262258 was reviewed on 2023-04-14.According to the dhr results, the product be-pvl 2355# passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.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 reported failure.The reported failure was also identified as part of the current risk management file (dms#(b)(4), v01) and the most probable cause is associated to: 1.Manufacturing: - inappropriate assembly of components production employees were informed about gluing&assembly to increase awareness on (b)(6) 2023.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: 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: 16642546
• MDR Text Key: 312605591
• Report Number: 8010762-2023-00154
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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,Followup
• Report Date: 05/26/2023

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 Model Number: BE-PVL 2355#
• Device Catalogue Number: 701047295
• Device Lot Number: 3000262258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NA.