MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.

Device Problem Improper Chemical Reaction (2952)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Further patient and perfusion data was requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that the co2 removal of a quadrox-id was lower than expected.Detailed description from customer below: pre membran oxygenator (mo) blood gas was ph: 7.39, co2:78, po2 33 and the post mo blood gas was ph: 7.42, co2: 70, and po2: 250.The customer felt like the post mo co2 should have been less than it was on 2 lpm of sweep gas.This is covid patient that has been on this disposable for 8 days.There was no patient harm and they do not plan to change out the disposable.They plan to increase the sweep gas and check a gas.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that during patient treatment with a quadrox-id the co2 removal rate was low.Oxygenation was in range.The device was being used for treatment.After communication with the customer it was determined that a blood to gas flow ratio of 1:4 was applied during treatment.According to the quadrox-id adult instructions for use chapter 6.3 "starting perfusion" a ratio of 1:1 with 80 % oxygen should be used.The gas flow settings should be checked shortly after beginning perfusion.If needed adjust the oxygen content and the gas/blood flow ratio to the measured values.As confirmed by the customer by increasing the sweep the blood values were corrected.The production records of the affected quadrox-id module (dms# 2809340, 2790217) were reviewed on 2021-09-03.Following steps are performed according to the bop with a 100 % inspection: pressure test, tightness test, coating test.According to the final test results, the oxygenator with the serial# 1389717 passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the investigation results no malfunction of the quadrox-id could be confirmed.The occurrence rate was calculated for the reported failure 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 id:(b)(4).

• Brand Name: QUADROX-ID ADULT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12030723
• MDR Text Key: 257137451
• Report Number: 8010762-2021-00358
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2021
• Patient Sequence Number: 1