MAUDE Adverse Event Report: OXYGENATORS; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number QUADROX-I ADULT

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.During operation, long time hypoxia has been reported by the customer.However there is no permanent damage to the patient.The product has been destroyed by the hospital and cannot be sent back.

Event Description

The oxygenation performance of the oxygenator decreases in the process of use.Oxygen concentration: 100%.Oxygen partial pressure: 40mmhg.Complete the operation after replacing the oxygenator.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary requested the product back for investigation however it was scrapped by customer.Therefore no technical investigation could be performed.In addition, device history record could not be reviewed since serial numbers on the product are not available.The cause of the failure could not be identified.Trend search was performed for reported issue and similar product.Additionally 13 complaints were recorded which appears reported issues are the same.Based on the sales figures of the last 12 months following occurrence rate has been calculated and found below accepted%.Due to this information no systemic issue could be determined at this time.Trend search shows that 9 complaints found not product related, 3 complaints are not closed yet and 1 complaint sample shows leakage.In this complaint, no leakage was reported.Therefore, at this time no similar complaint investigated was found which could led to the confirmation of the failure and / or a product related malfunction.The reported failure did not contribute to death or serious injury.In addition at this time it cannot be concluded that this is a systemic error.No further actions are required.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

Complaint: (b)(4).

• Brand Name: OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• MDR Report Key: 9586024
• MDR Text Key: 192166287
• Report Number: 8010762-2020-00013
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2019
• Device Model Number: QUADROX-I ADULT
• Device Catalogue Number: 70106.7941
• Device Lot Number: 92279368
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 63 YR