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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Abnormal Blood Gases (1034)
Event Date 05/26/2020
Event Type  malfunction  
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 partial pressure of oxygen (pao2) going on the pump was 300 millimeters of mercury (mm hg) and dropped to 200. The yellow cap on the gas egress was off. It was reported that the patient had a history of end-stage ischemic cardiomyopathy and left ventricular assist device (lvad) support prior to receiving heart transplantation. Post transplant the patient was placed on venous arterial extracorporeal membrane oxygenation (va ecmo) via central cannulation due to post operative pulmonary edema and primary graft dysfunction on (b)(6) 2020. The patient was weaned from va ecmo on (b)(6) 2020 and was proven to be stable. The patient was later returned to the operating room for emergent venous venous extracorporeal membrane oxygenation (vv ecmo) initiation due to cardiogenic shock secondary to right ventricular dysfunction status post heart transplantation and pulmonary hypertension. At this second initiation of ecmo, the oxygenator was used. There were no additional event details available. The patient was in right ventricle failure post heart transplant. The patient was weaned off ecmo after 3 days on support. The patient was put back on ecmo after being off support for 3 days.
 
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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 Key10149878
MDR Text Key196450641
Report Number0002916596-2020-03056
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 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS5062
Device Catalogue NumberUS5062
Device Lot Number5969906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 06/12/2020 Patient Sequence Number: 1
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