MAUDE Adverse Event Report: EUROSETS S.R.L. EUROSET OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number US5062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 10/19/2019

Event Type  Injury  

Manufacturer Narrative

From the preliminary analysis by manufacturer, the issue appears to be related to patient condition and anticoagulation.Since this is an unique case all other manipulations went very well.The product has been returned is currently under investigation at the manufacturer.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported there was difficulty getting the patient therapeutic on bivalirudin and the oxygenator clotted off.The oxygenator was subsequently exchanged the patient is ongoing on another manufacturer's device.No further information was provided.

Manufacturer Narrative

Section a3: correction.Manufacturer's investigation conclusion: the evaluation of the returned oxygenator revealed no device-related issues that could have contributed to the reported event of poor gas exchange and the device clotting off.The eurosets amg pmp oxygenator, lot number 5830806, was returned to abbott and an initial visual inspection was performed.The oxygenator was returned filled with blood.Visual inspection of the oxygenator showed no obvious cracks or damage to the external housing or ports.The oxygenator was then forwarded to the external manufacturer for technical analysis.Upon receipt at eurosets, the oxygenator was washed with a saline solution and dried before proceeding with the functional test.The functional test was performed using bovine blood with parameters compliant to international standards.The o2 and co2 gas transfer performance and the pressure drops across the oxygenator measured during the test were in line with the technical specifications.The manufacturer determined that the device was compliant with the product specifications and the reported event could not be correlated to a device-related issue.However, the reported information indicated that there was difficulty getting the patient therapeutic on bivalirudin and the ptt during the hospital procedure did not exceed 40 seconds.Based on international guidelines, which were noted to align with the hospital¿s bivalirudin protocol, the manufacturer suggests maintaining a ptt range of around 61-75 seconds.The production documentation for amg pmp oxygenator, lot number 5830806, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.The eurosets amg pmp instructions for use (ifu) is currently available.The section titled "intended use" explains that the amg module pmp no t.P.Sterile is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.The amg module pmp no t.P.Sterile is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.Contact with blood for a longer period of time is unadvisable.Under the list of warnings, the ifu warns that during the extracorporeal circulation (ecc) a backup oxygenator is necessary.Under the list of precautions, the ifu cautions that a strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures.The benefit of extracorporeal support must be weighed against the risk of systemic anticoagulation and must be assessed by the prescribing physician.Adequate heparinization must be maintained before and during bypass.The "priming and recirculation procedure" section warns to check the correct dosage of anticoagulant in the system before starting the bypass.The "bypass start" section states to check that anticoagulation level (act) is appropriate before starting the procedure.The "during bypass" warns that the act (activated coagulation time) must always be longer than or equal to 480 seconds in order to ensure adequate anticoagulation of the extracorporeal circuit.Under the section titled "oxygenator replacement", this document states that a spare oxygenator must always be available during perfusion.After 6 hours of use with blood or if particular situations occur, which may lead the person responsible for perfusion to determine that the safety of the patient may be compromised, (insufficient oxygenator performance, leaks, abnormal blood parameters etc.), follow the procedure outlined in the ifu for oxygenator replacement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: EUROSET OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• MDR Report Key: 9331159
• MDR Text Key: 166760846
• Report Number: 2916596-2019-05172
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• Combination Product (y/n): N
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 5830806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 87