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

Model Number BE-PVL 2555 -J#

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the hand (griff) of the introducer came off when the hls cannulae was inserted.The introducer was removed.Customer opened new hls cannulae and continue to ope.Some delay was occurred on treatment however there was not any impact on patient.Trackwise # (b)(4).

Manufacturer Narrative

It was reported that the handle (griff) of the introducer came off when the hls cannulae was inserted.The introducer was removed.Customer opened new hls cannulae and continue to ope.Some delay was occurred on treatment however there was not any impact on patient.The sample was investigated in the laboratory of manufacturer on 2023-05-11.Visual control has been performed for both introducer and handle.There was no damage detected on the sample (introducer and handle).Hardened glue residues were found on introducer and also in handle.It was found that a greater area of introducer is completely residue free.Based on the investigation, the failure could be confirmed.The production history record (dhr) of the affected be-pvl 2555 -j with lot# 3000275038 was reviewed on 2023-04-06.According to the dhr result, the product be-pvl 2555 -j 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 (handle) (batch # 3000199908) and introducer (batch # 3000237283 and # 3000237282) were reviewed on 2023-04-06.The griff (handle) 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.Review of the non-conformities has been performed.It does not show any non-conformity in regards to the reported product and failure.Based on the investigation results, the most probable cause has been found as: - manufacturing: failure of glue connection between introducer and handle.Production employees were informed about this complaint to increase awareness 2023-05-12.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: 16705243
• MDR Text Key: 313632898
• Report Number: 8010762-2023-00166
• 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: 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: BE-PVL 2555 -J#
• Device Catalogue Number: 701067505
• Device Lot Number: 3000275038
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/09/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1