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); 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.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the returned device confirmed the presence of an incorrectly placed one-way valve in the outlet luer port, which would have contributed to the reported difficulty back-flushing into the circuit.The amg pmp oxygenator, lot number 6013706, was returned to abbott and an initial visual inspection was performed.Visual inspection of the oxygenator showed no obvious cracks or damage to the external housing or ports.However, a one-way valve was observed in the outlet luer port.The oxygenator was forwarded to the external manufacturer for further analysis.Upon receipt at eurosets, visual inspection of the device confirmed that a one-way valve was incorrectly placed in the outlet luer port.The arterial line was pressurized with a 10 ml syringe, but it was not possible to inject water through the luer port.The findings were consistent with the presence of the one-way valve, which is intended to allow liquid to escape but not to enter.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 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.The production documentation for amg pmp oxygenator, lot number 6013706, was reviewed by the external manufacturer and showed no anomalies.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 41036 ; IT 41036
• MDR Report Key: 10465936
• MDR Text Key: 231681542
• Report Number: 3003752502-2020-00072
• 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
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• 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: 08/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 127