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

Model Number BE-PVL 2355#

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing.A follow-up medwatch will be submitted when further information becomes available.

Event Description

It was reported that the handle (griff) at the end of introducer, break (came off).Complaint #: (b)(4).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that the handle (griff) at the end of introducer, break (came off).It was occurred during cannula insertion.User was able to insert the cannula.No harm or death was reported.The product was investigated in the laboratory of manufacturer.The pictures show intact introducer components (griff and introducer body).The glue connection between the two components has been loosened.Based on this failure could be confirmed.Device history record for lot number 92309929 was reviewed on 2021-10-25.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.The process validation of the handle and introducer connection in regards to the gluing method, gluing parameters and test method was performed on 2020-09-18 and the reported lot number in this complaint was manufactured on 2021-10-16.Based on this manufacturing process related malfunctions can be excluded.The products are applied to 100% test with an equipment to fulfill the minimum tensile strength criteria.According to the production records of the lot number 92309929, this test was conducted and all products in this lot number were passed the test.Based on this, production related influences could be excluded.According to the investigation report, it is the most probable that an excessive force (unintended) was applied to the introducer which lead to the failed glue connection.It was reported within this complaint that ¿no extra force was applied.¿ however, the force cannot be measured and unintended movements could cause the handle disconnection.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
• MDR Report Key: 11954679
• MDR Text Key: 254806947
• Report Number: 8010762-2021-00335
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2022
• Device Model Number: BE-PVL 2355#
• Device Catalogue Number: 70104.7295
• Device Lot Number: 92309929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Date Manufacturer Received: 10/04/2021
• Patient Sequence Number: 1