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

Model Number HLS CANNULA + PIK

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 05/01/2023

Event Type  malfunction  

Event Description

"when i used it, i noticed that the cap of the introducer was broken.Therefore, it is determined that it cannot be used, and another product is used.No harm to patient's health." complaint #: (b)(4).

Manufacturer Narrative

This is a combined emdr.It was reported that when customer used it, he noticed that the cap (griff) of the introducer was broken.The white cap came off when the customer opened the product.The introducer was not broken, so the customer pushed in the white cap and used it.No harm to patient's health.This issue is known to manufacturer.A similar failure was investigated in a previous complaint. based on this, the complaint could be confirmed.The production history record (dhr) of the affected (b)(6) with lot# 3000275040 was reviewed.According to the dhr result, the product (b)(6) 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 # 3000237283) were reviewed.The griff was checked visually for particles, pressure marks, rills, streaks, sinks, fat, dirt, blur, cords, scratches, burrs, bubbles and also measured for diameter (inner).The introducer was checked visually for ridges, sharp edges, cracks, streaks, dirt, spots, bubbles and also measured for diameter (outer).All tests were passed as per specifications.The reported failure was identified as part of the current risk management file 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.

• 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: 16938308
• MDR Text Key: 315448589
• Report Number: 8010762-2023-00217
• 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: 05/16/2023

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: HLS CANNULA + PIK
• Device Catalogue Number: 701067505
• Device Lot Number: 3000275040
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose