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

Model Number BE-PAS 1315

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that when the product was introduced to a patient, the hub part (handle / griff) of introducer came off.Customer opened a new product and introduced it without any problem.There was not any impact on patient.No harm to patient was reported.The product is not available for investigation.The reported failure caused the customer to product change and the reported failure is known to manufacturer.Based on these, the failure could be confirmed.The production history record (dhr) of the affected be-pas 1315 with lot# 3000221948 was reviewed on 2023-09-05.According to the dhr result, the product be-pas 1315 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Further, the incoming inspection reports of the affected components griff (batch # 20-9202401) and introducer (batch # 3000164624) were reviewed on 2023-09-05.The griff was checked visually according to the receiving inspection plan ri-437, v01 for particles, pressure marks, rills, streaks, sinks, fat, dirt, blur, cords, scratches, burrs, bubbles, black dots 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#3186956, 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.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

It was reported that when the product was introduced to a patient, the hub part (handle / griff) of introducer came off.Customer opened a new product and introduced it without any problem.There was not any impact on patient.No harm to patient was reported.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: 17687973
• MDR Text Key: 322701416
• Report Number: 8010762-2023-00444
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2024
• Device Model Number: BE-PAS 1315
• Device Catalogue Number: 701053276
• Device Lot Number: 3000221948
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other