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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 50000 #
Device Problem Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation is ongoing. A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that there were three episodes of hypoxia during the operation. Twice the oxygen saturation of the superior vena cava went from %80+ to 30+ and 50. Complaint: #(b)(4).
 
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Brand NameOXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key12243916
MDR Text Key264041192
Report Number8010762-2021-00419
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K090689
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 10/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVKMO 50000 #
Device Catalogue Number70106.7966
Device Lot Number92303893
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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