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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROSETS S.R.L. AMG EUROSETS OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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EUROSETS S.R.L. AMG EUROSETS OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Lot Number 6183306F0055
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2020
Event Type  malfunction  
Event Description
Patient cannulated for vv ecmo in the (b)(6) ed for ards at 1409. Patient stabilized and transferred to (b)(6) at 1530. Po2 on abg's were minimally improved despite vent manipulation and high flow vv ecmo. A post oxygenator abg was taken at 1659 which showed a po2 of 80mmhg. Perfusionists, then confirmed all settings with ecmo circuit were appropriate and sample was redrawn at 1705 with a po2 of 85. Suspecting a possible blender issue they then placed the oxygenator on an 02 tank and drew another post oxy abg, which had a po2 of 86. This indicates an acute failure in the oxygenator. The original oxygenator was an amg eurosets, lot# 6183306f0055. This oxygenator was then immediately changed out at 1745 to a quadrox oxygenator lot# 70137479. Post oxy po2 was 348mmhg from the new oxygenator. Fda safety report id# (b)(4).
 
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Brand NameAMG EUROSETS OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
EUROSETS S.R.L.
MDR Report Key10082322
MDR Text Key191985064
Report NumberMW5094636
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number6183306F0055
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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