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

Model Number US5062

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Information not provided.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The site communicated that they used an oxygenator on an ecmo circuit that was used to place a patient on support when the nurse caring for the patient noticed that there was blood dripping from the base of the oxygenator.The nurse caring for the patient was doing a circuit assessment and noticed that there was blood dripping from the base of the oxygenator.The blood seemed to be dripping from a seam that is formed at the base of the oxygenator and the clear cone.The oxygenator was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted photographs confirmed the report of blood dripping from within the lower orange housing of the device.It was reported that the oxygenator had been in use from approximately 17:15:00 on (b)(6) 2020 through approximately 06:30:00 on (b)(6) 2020.During a circuit assessment, the appointed nurse reportedly observed blood dripping from the base of the oxygenator.It was noted by the nurse that the blood appeared to have been dripping from the location where the clear protective cone was contacting the lower orange housing and the lower blue housing.It was reported that the oxygenator was performing well, but because of the reported leakage, an oxygenator exchange would need to be performed.It was reported that due to the patient¿s covid diagnosis, the eurosets amg pmp oxygenator, lot number 6365507, would not be returned for evaluation.The eurosets amg pmp oxygenator, lot number 6365507, was not returned for investigation; therefore, a specific cause for the reported blood leak could not be conclusively determined through this evaluation.However, eurosets indicated that this type of leak could have resulted from damage to a fiber that occurred at some point following the manufacturing and testing phases (see attached complaint investigation report authored by eurosets personnel).The production documentation for amg pmp oxygenator, lot number 6365507, was reviewed by eurosets 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.Under the list of warnings, the ifu warns that during the extracorporeal circulation (ecc) a backup oxygenator is necessary and also warns that the extracorporeal circulation has to be carefully and continuously checked.Also under the list of warnings, the ifu warns that ¿before using the product it is advisable to carefully inspect it.Shipping and handling could cause structural and functional damage to the device.¿ the section "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 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 6365507, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.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: 10514330
• MDR Text Key: 206555047
• Report Number: 3003752502-2020-00003
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 6365507
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 88