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

Model Number BEQ-PVL 2555-USA

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

"cannula introducer break on assembly during a cannulation.Patient was unaffected, staff had minimal delay in care and were able to cannulate after opening another cannula." complaint #: (b)(4).

Manufacturer Narrative

It was reported there cannula introducer break on assembly during a cannulation.They were able to cannulate after opening another cannula.Patient was unaffected.The staff had minimal delay in care.The product was scrapped.The photograph provided by the customer shows the disconnected girff and introducer.The failure could be confirmed.The production history record (dhr) of the affected beq-pvl 2555-usa# with lot # 3000249813 was reviewed.According to the dhr results, the product beq-pvl 2555-usa# 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 # 3000222613) were reviewed.The griff was checked visually for pressure marks, rills, streaks, sinks, cords, bubbles, scratches, burrs, and also measured for diameter (inner).The introducer was checked visually for ridges, sharp edges, cracks, streaks, 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.H3 : 4115.

Event Description

"cannula introducer break on assembly during a cannulation.Patient was unaffected, staff had minimal delay in care and were able to cannulate after opening another cannula." complaint #: (b)(4).

Manufacturer Narrative

Additional information: the medwatch report # mw5118331 received through the fda¿s medwatch program is the same with the information provided as reported under this complaint- onetrack # (b)(4).It was reported there cannula introducer break on assembly during a cannulation.They were able to cannulate after opening another cannula.Patient was unaffected.The staff had minimal delay in care.The product was scrapped.The photograph provided by the customer shows the disconnected girff and introducer.The failure could be confirmed.The production history record (dhr) of the affected beq-pvl 2555-usa# with lot # 3000249813 was reviewed.According to the dhr results, the product beq-pvl 2555-usa# 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 # 3000222613) were reviewed.The griff was checked visually for pressure marks, rills, streaks, sinks, cords, bubbles, scratches, burrs, and also measured for diameter (inner).The introducer was checked visually for ridges, sharp edges, cracks, streaks, 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: 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 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.H3 other text : 4115.

• 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: 17142176
• MDR Text Key: 317302280
• Report Number: 8010762-2023-00294
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/07/2023,06/27/2023

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: BEQ-PVL 2555-USA
• Device Catalogue Number: 701053093
• Device Lot Number: 3000249813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2023
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1