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

Model Number QUADROX-I SMALL ADULT/ADULT

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.The product was discarded by the customer.

Event Description

The oxygenation performance decreased in use.No injury was caused to the patient.Complaint#: (b)(4).

Manufacturer Narrative

The vkmo 78000 was directly involved in the incident which occurred during surgery.It was reported that oxygenation performance decreased in use.No injury was caused to the patient.The affected product was not available for a manufacturer's laboratory investigation as it was discarded by the customer.Thus a laboratory investigation was not possible.Device history record for vkmo 78000 was reviewed.No deviation was found during the manufacturing and final release of this product.However, as serial # of the affected product is not available, neither the device history record of the oxygenator nor possible related production non-conformances could be reviewed.A review of similar quadrox-i small adult/adult complaints was performed with the following outcome: a similar complaint with an already conducted laboratory investigation was found (#(b)(4)).The investigation results were as follows: the returned sample was investigated and a leak test in accordance with lv 201 was performed.A leak on the gas outlet was detected.In this case, the reported failure could be confirmed.Due to the leak through the gas outlet, a pressure drop may have occurred.The most probable root cause for the reported failure "bad oxygenation" could be determined as: inadequate pur encapsulation of the mats considered in the oxygenator.Based on this the reported failure could be confirmed.Trend search was performed.At this time it cannot be concluded that this is a systemic error.The information obtained so far in this investigation is not sufficient to determine the exact root cause.The reported failure was identified as part of the current risk management file (dms #1464420 v17) and the most possible root causes are associated with, - lack of information on pressure drop/pressure increase, - wrong design: inappropriate possibility of visual inspection, - damaged oxygenator due to mechanical forces, chemical agents or onstructed by particles.Mitigations for this specific failure are in place as per instruction for use warnings and design specifications in order to reduce of similar failures.The reported failure did not contribute to an actual death or serious injury nor is there a potential for death or serious injury.In addition, at this time it cannot be concluded that this is a systemic error.No corrective action 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 : the device was discarded by the customer.

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
• MDR Report Key: 10828494
• MDR Text Key: 216336752
• Report Number: 8010762-2020-00386
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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: 04/18/2021
• Device Model Number: QUADROX-I SMALL ADULT/ADULT
• Device Catalogue Number: 70106.7941
• Device Lot Number: 92279366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1