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); Mechanical Problem (1384)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

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 the site used the oxygenator for a total of 4 hours and 15 minutes.3 hours into the run with blood leakage the post oxygenator pao2 was 311 pre oxygenator pao2 was 62 with a hemoglobin of 6.1 with foaming.The site swapped the oxygenator to a quadrox and the oxygenator was discarded so it is not available for evaluation.

Manufacturer Narrative

Section a: patient information was requested but not provided.Manufacturer's investigation conclusion: review of the submitted photographs confirmed the report of foamy discharge within the lower orange housing of the device, indicative of leakage.It was reported that the oxygenator had been in use for a total of 4 hours and 15 minutes.After approximately 3 hours of use, there was blood leakage with post-oxygenator partial pressure of oxygen (pao2) measured at 311 millimeters of mercury (mmhg) and pre-oxygenator pao2 measured at 62 mmhg with hemoglobin of 6.1.Foaming was also noted.The oxygenator was exchanged for another manufacturer¿s device.The oxygenator was discarded and is not available for evaluation.It was reported that there were no adverse consequences to the patient.The eurosets amg pmp oxygenator, lot number 6183306, was not returned for investigation; therefore, a specific cause for the reported blood leak could not be conclusively determined through this evaluation.The production documentation for amg pmp oxygenator, lot number 6183306, was reviewed by the manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.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.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 6183306, 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: 10740609
• MDR Text Key: 227634099
• Report Number: 3003752502-2020-04152
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 6183306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1