MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMOD 70000-USA

Device Problems Excess Flow or Over-Infusion (1311); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Have a patient on va ecmo that has blood flows of over 8 liters and sweep gas of 10+ liters.The post oxygenator po2 was greater than 300 mmhg so oxygenation is not the issue it is the co2 removal ( 50-60).The question being that if the oxygenation responds to the high flow, why doesn¿t the co2? do not have current blood gases that are close enough in time to make comparisons so i know that that makes it harder to evaluate.The patient probably needs to be on vv ecmo instead of va ecmo but he cannot tolerate being off ecmo to make the change at this point.(b)(4).

Manufacturer Narrative

(b)(4).A quadrox-i adult was returned to the factory and investigated in the decontamination / complaints laboratory.No clots were visible on the blood inlet and blood outlets sides.No blood clots were visible on flushing out the oxygenator.The oxygenator was cleaned with sodium hypochlorite solution.On the luer lock of the blood outlet connector, a crack along the length of the luer lock was found and documented.A leakage test was performed and a leak was confirmed at the luer lock through the crack.The crack was sealed with glue, and then the leakage test was performed again, this time with no leaks.Note that there was no allegation by the customer that the luer lock was cracked or that there was a leak, therefore it is considered that crack must have occurred during the process of returning the product to the factory for investigation, therefore no further action is warranted for this issue.For further examination, the product was forwarded to the qa laboratory.Where the product was tested for its gas exchange performance for o2 and co2, and also a pressure drop test was performed.The product passed all the performance tests and was found to be working as specified.The issue was referred to the therapy application manager for his clinical assessment, and in his opinion, the customer's reported issue does not represent a complaint, but rather a request for information.The customer is asking about co2 removal.The product is delivered with an ifu which provides information about gas exchange performance.No further investigation or action is warranted in addition to continued periodic monitoring, and the complaint will be closed.This is the final report.

Event Description

Ref.: # (b)(4), customer ref.: (b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6103168
• MDR Text Key: 60427872
• Report Number: 8010762-2016-00674
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: HMOD 70000-USA
• Device Catalogue Number: 70105.3815
• Device Lot Number: 70107066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1