MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number US5062

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thromboembolism (2654); Thrombosis/Thrombus (4440)

Event Date 04/11/2020

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

The site communicated that during priming there was no issues.Soon after going on pump, the outlet pressure port would flush sluggishly and would not draw with pressures reading tremendously high.Both the specialist and perfusionist trouble shot and could not come up with anything.The site ended up capping the pressure line and leaving it.At the time of the call it sounded like there was a clot in the pigtail which is what was causing the inability to flush forward.The site thought that it t was likely a thrombus and elected to not change the device.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the returned device confirmed an issue that would have contributed to the report of high pressure readings and the inability to flush the outlet pressure monitoring port.The amg pmp oxygenator, lot number 6013706, was returned to abbott and an initial visual inspection was performed.The device was returned filled with blood.Visual inspection of the oxygenator showed no obvious cracks or damage to the external housing or ports.However, a white object was observed in the luer port adjacent to the arterial outlet.The oxygenator was forwarded to the external manufacturer for analysis.Upon receipt at eurosets, the oxygenator was washed with saline solution and dried.It was immediately difficult to drain the water from the oxygenator, which was brought to a reduced flow of 0.5 lpm to prevent damaging the device.The flow was subsequently increased to 1.0 lpm, after which an obstruction of coagulated blood was observed.The arterial line was then pressurized, resulting in the extraction of a clot with considerable dimensions.However, the outlet luer port was still observed to be blocked.A syringe was used to aspirate the remaining clots, after which a one-way valve was identified within the outlet luer port.The external manufacturer concluded that the reported event was due to the presence of the one-way valve in the outlet luer port.It was determined that the one-way valve was placed within the outlet luer port in error during the manufacturing process.The external manufacturer initiated a capa to address the issue.The production documentation for amg pmp oxygenator, lot number 6013706, was reviewed by the external manufacturer and showed no anomalies.The eurosets amg pmp instructions for use (ifu) is currently available.Under the list of warnings, the ifu warns that during the extracorporeal circulation (ecc) a backup oxygenator is necessary.The section titled "during bypass" states that for arterial blood sampling, connect a dedicated sampling line equipped with one-way valve (to allow suction only) to the female luer-lock connector (positioned on the arterial outlet).Under "circuit connections", the ifu warns that when performing arterial sampling, the arterial sampling line must be equipped with a one-way valve to prevent unwanted ingress of air.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: ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena CA 41036 ; IT 41036
• MDR Report Key: 10058328
• MDR Text Key: 191102663
• Report Number: 2916596-2020-02610
• Device Sequence Number: 1
• Product Code: DTZ
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 6013706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 77