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

Model Number VKMO 78000

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that oxygenator caused bleeding.The failure was found to have no effect on the patient.Complaint: #(b)(4).

Event Description

Complaint: (b)(4).

Manufacturer Narrative

It was reported that leakage at blood outlet side of oxygenator caused bleeding.The failure was found to have no effect on the patient.The received information states that the leakage at oxygenator outlet side.Received photograph doesn't show the exact point however it is confirmed that the leakage was at the blood outlet side of oxygenator.Since the product was discarded by customer, laboratory investigation could not be performed.The production records of the affected quadrox-i (dms# (b)(4)) were reviewed on 2021-11-17.Following tests are performed according to the bop 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 with the serial# 1584620 passed the test as per specifications.Production related influences can be excluded.The lot number of vkmo 78000 could not be provided.The products sold to china with oxygenator lot 70139978 identified via sap.Two lot numbers were identified: 92312122; 92311063.Device history records for these 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.Since affected part is not available, the exact cause could not be determined.However the reported failure could be linked to the risk assessment and control quadrox-i small adult/adult, quadrox-id adult (dms#(b)(4), v17) and the most probable cause could be: - use errors: lack of attention on device handling; - transport of product (excessive physical force).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 user.

• 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: 12566979
• MDR Text Key: 274428065
• Report Number: 8010762-2021-00538
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 78000
• Device Catalogue Number: 701067941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1