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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number VKMO 71000
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2023
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that the pressure was not increase on oxygenator, and an oxygenation problem occurred at 100% po2 70 mmhg.Customer changed the product and po2 increased over 300 mmhg.No harm or death to any person was reported.Complaint (b)(4).
 
Event Description
Complaint #(b)(4).
 
Manufacturer Narrative
It was reported that the pressure was not increase on oxygenator, and an oxygenation problem occurred at 100% po2 70 mmhg.Customer changed the product and po2 increased over 300 mmhg.No harm or death to any person was reported.The sample was investigated at maquet cardiopulmonary gmbh laboratory on 2024-01-23.A visual control was performed for any kind of damages, deformations, cracks.There could not be found any damage on the oxygenator.The product was checked for clots, and there could not be found any clots on blood inlet neither on blood outlet of oxygenator.Further, blood side, water side and gas side were rinsed out with tap water, no clots were flushed out.Pressure increase was not observed.Tightness test of the blood side was passed successfully, there was no leakage detected during the test period of 6 hours.Integrity tightness tests of the blood- and of the gas side have passed.As per the laboratory results, there is no indication of any technical cause behind the insufficient oxygenation.Thus, the failure could not be reproduce and therefore could not be confirmed.The production history record (dhr) of the affected quadrox-i adult with lot # 3000335432 was reviewed on 2024-01-22.According to the dhr results, the product quadrox-i adult passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The production history record (dhr) of the affected vkmo 71000 with lot# 3000346027 was reviewed on 2023-12-07.According to the dhr result, the product vkmo 71000 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Based on the investigation results, there could not be found any failure that is related with product and product¿s performance.The exact cause of the failure could not be determined.The occurrence rate was calculated for the reported failure and product 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.
 
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Brand Name
OXYGENATOR
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key18236461
MDR Text Key329330614
Report Number8010762-2023-00596
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVKMO 71000
Device Catalogue Number701067949
Device Lot Number3000346027
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2023
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Other;
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