MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 50000

Device Problem Material Rupture (1546)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tube burst during the operation.The operation was completed by replacing a new oxygenator and tubing.Complaint: #(b)(4).

Manufacturer Narrative

It was reported that the pipe(tube) burst during the priming in the product vkmo 50000.A video was received showing staff changing the product however no pipe burst could be detectable.Additional information was requested for this issue and it was reported that user could not remember the specific burst location of the pipe.The product was received back and investigated in the laboratory of manufacturer.The delivery included a quadrox-i small adult oxygenator and reservoir vhk 71000, a manifold with two sample lines and a hose with a y connector.Visual inspection revealed external scratch marks on vhk and broken plastic part at the lower round suspension where oxygenator is attached.Also external damage was also found on the oxygenator label area.The exact reason for these damages is unknown.These damages were not reported in the initial complaint description by customer.Therefore it could be most likely occurred during further handling of sample return.A leakage test was performed on the blood side.No leaks could be found.A leak test in the water-side showed no pressure drop which means that this test was passed.When the system was filled, there were no abnormalities that lead to an increase in pressure and cause the connections to loosen or burst.The subsequent leak tests on the blood side and water side were passed.No technical cause could be determined that led to the complaint.Based on this failure could not be confirmed.No product malfunction could be identified.However the reported failure could be linked to product risk assessment and control vhk & vkmo, vkmod 5/7 (dms #1998588 v5a) and the most probable cause could be user error: lack of attention on product handling.Device history record for both lot numbers were reviewed.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.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

Complaint: # (b)(4).

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, 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: 12243869
• MDR Text Key: 264041092
• Report Number: 8010762-2021-00418
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 50000
• Device Catalogue Number: 70106.7966
• Device Lot Number: 70138011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1