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

Model Number BE-PAS 2115

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 04/03/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the white part (griff) of the introducer came off during on patient use.Customer use a spare hls cannulae, no harm to patient was reported.(b)(4).

Manufacturer Narrative

It was reported that the white part (griff) of the introducer came off during on patient use.Customer use a spare hls cannulae, no harm to patient was reported.The production history record (dhr) of the affected be-pas 2115 with lot# 3000211935 was reviewed on 2023-04-06.According to the dhr result, the product be-pas 2115 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 # 3000188930) and introducer (batch # 3000186977 and # 3000175921) were reviewed on 2023-04-06.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 (dms# (b)(4), v01) and the most probable causes are associated to: 1.Manufacturing: inappropriate assembly of components 2.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 3.User: loosening of handle from introducer.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.

Event Description

Trackwise # (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: 16705241
• MDR Text Key: 313027007
• Report Number: 8010762-2023-00170
• 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,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: BE-PAS 2115
• Device Catalogue Number: 701047283
• Device Lot Number: 3000211935
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1