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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 Infusion or Flow Problem (2964)
Patient Problems Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient was placed on extracorpeal membrane oxygenation (ecmo) in the catheterization lab. Upon initiation of support, the pre-oxygenation pressures of the eurosets oxygenator exceeded 350 mmhg. Despite this, flow was unable to surpass 3. 5 liters per minute, no matter how high the centrimag¿s rotations per minute were increased. Pressure alarms sounded and were also displayed. The eurosets oxygenator was exchanged and support to the patient was resumed.
 
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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 Key12623699
MDR Text Key282120327
Report Number3003752502-2021-00011
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS5062
Device Catalogue NumberUS5062
Device Lot Number7081108F0265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2021 Patient Sequence Number: 1
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