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

Model Number VKMO 70000

Device Problem Free or Unrestricted Flow (2945)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was one spot blood from the de-airing membrane with yellow protective cap of quadrox-i adult.The failure was noticed after 90 minutes into the cpb run.No issue was reported with oxygenator function.The case was successful.Complaint: #(b)(4).

Event Description

Complaint: (b)(4).

Manufacturer Narrative

It was reported that there was one spot blood from the de-airing membrane with yellow protective cap of quadrox-i adult.The customer saw 1 drop of blood from the de airing membrane.It did not continue to leak.The customer did not change the product.The product was used entire operation.No harm or death was reported.The investigation was performed based on photograph provided by customer.It could be seen that there is a blood residue on the de-airing membrane part of oxygenator.Also there is a drop residue at the bottom of the luer.Based on this the reported failure "1 drop of blood leak from the de airing membrane" could be confirmed.The device history record for lot number 70139987 was reviewed.The production records of the affected quadrox-i (dms# 2983252) were reviewed.Following tests are performed as a 100 % inspection: leak test after welding, pressure test heat exchanger, leak test water side, leak and flow test gas side, pressure test blood side.According to the final test results, the oxygenator passed the test as per specifications.Production related influences can be excluded.Since the product is not available for technical investigation an exact root cause cannot be determined.However the failure mode "leakage de-airing port" can be linked to the following most possible root causes according to our risk management file (dms#1464420): damage (s) to the de-airing membrane.The production records of the affected quadrox-i adult were checked and according to the final test results, the oxygenators passed all tests as per specifications.Production related influences can be excluded.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 : used and discarded.

• 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: 12567939
• MDR Text Key: 274449494
• Report Number: 8010762-2021-00540
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

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 Expiration Date: 10/29/2022
• Device Model Number: VKMO 70000
• Device Catalogue Number: 70106.7942
• Device Lot Number: 92311143
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1