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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS

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EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number US5062
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2021
Event Type  malfunction  
Event Description
Related manufacturer¿s report #3003752502-2021-00001. It was reported that a member of the perfusion team was priming a eurosets oxygenator and noticed that there was priming fluid leaking inside of the oxygenator at the bottom near the blood inlet connection. The oxygenator was removed and a second eurosets oxygenator was primed, but the same experience occurred where there was priming fluid leaking inside the oxygenator at the bottom. The oxygenator was removed and a third eurosets oxygenator was primed with no leaking observed.
 
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Brand NameADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
EUROSETS S.R.L.
strada statale 12, n°143
medolla, modena 41036
IT 41036
Manufacturer (Section G)
EUROSETS S.R.L.
strada statale 12, n°143
medolla, modena 41036
IT 41036
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key11308987
MDR Text Key245102230
Report Number3003752502-2021-00002
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141492
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 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS5062
Device Lot Number6365407
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2020
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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