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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemolysis (1886); Inflammation (1932); Septic Shock (2068); Jaundice (2187); Lactate Dehydrogenase Increased (4567)
Event Date 10/04/2020
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported that the doctor was concern that the oxygenator caused severe hemolysis and inflammation. The patient had an hm3 implanted on (b)(6) 2020 with a protek duo/lifesparc inserted later in the day (b)(6) 2020 along with amg/pmp oxygenator. Oxygenator was changed out on (b)(6) 2020 when ldh (lactate dehydrogenase) was noted to be 3190. Ldh remained elevated and oxygenator was discontinued on (b)(6) 2020 at 5 pm. Ldh on (b)(6) 2020 was 2030 and (b)(6) 2020 1500. Patient remains on protek and lifesparc on the right side with hm3 on the left.
 
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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 Key10719029
MDR Text Key216866248
Report Number3003752502-2020-04150
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,Followup,Followup
Report Date 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUS5062
Device Catalogue NumberUS5062
Device Lot Number5836706
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/10/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2019
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: 10/22/2020 Patient Sequence Number: 1
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