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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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
(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).
 
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).
 
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Brand NameOXYGENATOR, CARDIOPULMONARY BYPASS
Type of DeviceOXYGENATOR, 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 Key6103168
MDR Text Key202859331
Report Number8010762-2016-00674
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received11/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2017
Device Model NumberHMOD 70000-USA
Device Catalogue Number70105.3815
Device Lot Number70107066
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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