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

Model Number BE-PAS 2115#

Device Problem Premature Separation (4045)

Patient Problems Cardiac Arrest (1762); Hypovolemia (2243)

Event Date 04/29/2021

Event Type  Death  

Manufacturer Narrative

Investigation is still ongoing.Product and further information about the event have been requested but not received yet.A follow-up report will be sent when further information becomes available.

Event Description

It was reported that jugular cannula torn off.The blood exploded on customer gas blender (sechrist) and rotaflow (maquet) and according to the healthcare executive, the cannula was ejected from the equipment.The patient died.The issue is linked to the complaint (b)(4).Complaint #(b)(4).

Event Description

Complaint#: (b)(4).

Manufacturer Narrative

It was reported that jugular cannula torn off.The blood exploded on customer gas blender (sechrist) and rotaflow (maquet) and according to the healthcare executive, the cannula was ejected from the equipment.The patient died.The product is not available for investigation as it was discarded by the customer.On 2021-06-24, the user facility confirms that the accidental decannulation of the ecmo right jugular reinjection cannula is directly related to a rupture of the cannula fixation suture.The death was not attributed to the device.The medical review shows, the decannulation of the patient was not the result of the product.Moreover, from the details provided in the context of the complaint, it is not known whether the decannulation event, an increase in clinical complexity, or an undiagnosed comorbidity, was/were the root cause(s) of the patient¿s expiration.The hls cannula instructions for use stresses the importance of securely anchoring the cannula to the vessel or surrounding tissue to prevent the accidental dislocation during the extracorporeal circulation.If, as the customer described in this complaint, the cannula is not properly secured with sutures, then dislocation of the cannula may occur with the possible result of decannulation.The root cause of the decannulation event does not appear to be related to product malfunction or a decrease in product performance, but to the loss of cannula securement to the surrounding tissues.Based on these information, the cause of the event could not be attributed to the device.The cause could be cannula fixation suture as reported by customer.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: discarded by customer.

• 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: 11789016
• MDR Text Key: 249416603
• Report Number: 8010762-2021-00291
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BE-PAS 2115#
• Device Catalogue Number: 70104.7283
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death