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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 Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 04/25/2020
Event Type  Injury  
Manufacturer Narrative
No additional information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported that the patient on ecmo support needed quadrox oxygenator changed. It was stated that the patient was in bad shape and urgently swapped oxygenator in the ecmo circuit to amg eurosets. As soon as support was started a slow dripping of blood leaked near port of arterial blood outlet. They tried to apply bone wax to the port to stop leak and this did not help. After a few minutes on the amg euroset oxygenator the decision was made to replace the oxy with a quadrox oxy. It was reported that the patient was very unstable prior to going on amg and does not feel this impacted the patients condition. Cardiologist is requesting analysis of amg oxy. The patient was in "bad shape" prior to even placing the patient on amg oxygenator. No further information was provided.
 
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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 Key10079873
MDR Text Key195003440
Report Number3003752502-2020-00001
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was 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 Model NumberUS5062
Device Catalogue NumberUS5062
Device Lot Number6183306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2020
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: 05/21/2020 Patient Sequence Number: 1
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