• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number US5062
Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thromboembolism (2654); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2020
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 when performing normal pigtail flushing following a lab draw, it was found to be extremely difficult to push back into the circuit. Clearly some form of obstruction, but did not seem as though there would be clot as the anticoagulation status was adequate, with no other visible signs of clots noted throughout the circuit. For fear of there being a clot, the process was discontinued. Without this finding communicated further, some days later, the nurse found that though there was resistance, the port flushed to the circuit. With a subsequent attempt a few hours later to do maintenance flushing by the same nurse, it was found that the port would again, not flush to the circuit. So there would be times when the valve would seem compromised in a way allowing the ability to flush to the circuit, and then at times, the integrity of the valve was recaptured and then did not allow for flushing. The plan was to possibly have the ecmo system removed soon, so the hope is to leave the device until removal, and will be shipped back to abbott. The patient has been extubated since on the device, and is seemingly doing quite well currently.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10465936
MDR Text Key231681542
Report Number3003752502-2020-00072
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 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS5062
Device Catalogue NumberUS5062
Device Lot Number6013706
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-