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

Model Number BE-PVL 2555#

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 03/09/2023

Event Type  malfunction  

Event Description

It was reported that the white part at the hand of the introducer came off.The hls cannula was changed with new one.It was occurred when the phisician pull the dilater during cannulation.No harm to any person was reported.Complaint #: (b)(4).

Manufacturer Narrative

It was reported that the white part at the hand of the introducer came off.The hls cannula was changed with new one.On 2023-03-28 getinge representative reported the incident time as during cannulation.The production history record (dhr) of the affected be-pvl 2555#with lot#3000256275 was reviewed.According to the dhr results, the product be-pvl 2555# 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 failure.Further the incoming inspection reports of the affected components griff (batch # 3000199908) and introducer (batch # 3000237279) were reviewed.The griff was checked visually for particles, pressure marks, rills, streaks, sinks, fat, dirt, blur, cords, scratches, burrs, bubbles and also measuremental for diameter (inner).The introducer was checked visually for ridges, sharp edges, cracks, streaks, dirt, spots, bubbles and also measuremental for diameter (outer).All tests were passed as per specifications.The reported failure was identified as part of the current risk management file (dms#3186956, v01) 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 due to the fact that the customer changed the hls cannula with a new one, the complaint could be confirmed.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.

• 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: 16705242
• MDR Text Key: 313632979
• Report Number: 8010762-2023-00161
• 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: 04/07/2023

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 2555#
• Device Catalogue Number: 701047296
• Device Lot Number: 3000256275
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1