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

Model Number US5062

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

No patient was involved in this event.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 customer was setting up and acute extracorporeal life support (ecls) circuit to include the oxygenator.When the customer was trying to connect the pigtail high pressure tubing to the ports of the oxygenator it was noted that the seal was not tight and the tubing was falling off.The customer tried several other high pressure tubing connections with the same outcome.The customer set the dry unused oxygenator with the faulty port aside and opened a new sterile oxygenation to connect to the circuit.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the returned oxygenator did not confirm the report that the pigtail tubing would not properly connect to the port.The eurosets amg pmp oxygenator, lot number 5836706, was returned to abbott and a preliminary inspection was performed.The oxygenator was returned with pigtail tubing attached to both the inlet and outlet luer ports.Visual inspection of the oxygenator¿s external housing and ports revealed no obvious damage or anomalies.The returned pigtail tubing and a test pigtail tube were able to be disconnected and connected to the ports without issue.The production documentation for amg pmp oxygenator, lot number 5836706, was reviewed by the external manufacturer eurosets and showed that all tests from the production process were compliant with the technical specifications.Eurosets also reviewed the photographs of the luer pressure port extending from the blood inlet port submitted by the customer and did not identify any anomalies.The oxygenator was forwarded to eurosets for technical analysis.The manufacturer¿s evaluation revealed no evidence of damage or other anomalies to the luer pressure port extending from the blood inlet port.Several pressure lines were able to be successfully connected to the port.It was determined that the device was compliant with product specifications.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.Under the section titled "circuit connections", the ifu contains the following information: pressure lines: connect the pressure lines to oxygenator blood venous inlet and blood arterial outlet screwing them into the dedicated luer ports.Arterial sampling line: remove the protective cap from the luer connector positioned on the arterial outlet and connect an arterial sampling line with male luer port.Under the section titled "oxygenator replacement", this document states that a spare oxygenator must always be available during perfusion.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d4: correction; previous report included (b)(6), as the serial number but it is the lot number.

• 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: 9715520
• MDR Text Key: 180195696
• Report Number: 2916596-2020-00596
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: US5062
• Device Lot Number: 5836706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1