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

Model Number US5062

Device Problems Improper Chemical Reaction (2952); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pneumonia (2011); Pulmonary Dysfunction (2019); Pulmonary Edema (2020); Low Oxygen Saturation (2477); Cough (4457)

Event Date 05/15/2023

Event Type  Injury  

Event Description

It was reported that the patient was cannulated with an oxygenator for cardiogenic shock with impella for ventilation.The patient later experienced a cough, respiratory desaturation, and pulmonary decompensation on (b)(6) 2023.The post-partial oxygen pressure (pao2) was noted to be 110 mmhg; the oxygenator was exchanged.The patient tolerated the exchanged; however, from (b)(6) 2023 to (b)(6) 2023 the patient continued to experience respiratory decompensation, with a pao2 of 100 mmhg and post-partial carbon dioxide (paco2) of 75 mmhg.The patient's radial pao2 was 131 mmhg, and radial paco2 was 36 mmhg.The patient's venous gas paco2 was noted to be 51 mmhg.The patient's oxygen support was moved from a blend of extracorporeal membrane oxygenation (ecmo) and an oxygen tank to full support on an oxygen tank and increased ventilation support.Related oxygenator mfr #: 3003752502-2023-02389.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

Additional information reported that the cause of the patient's respiratory decompensation was pulmonary edema and pneumonia.Prior to the decision to exchange the oxygenator, blood flow and gas flow rates were 5 lpm and 3 lpm, respectively.After the oxygenator exchange, blood flow and gas flow rates were 5 lpm and 1 lpm, respectively.The patient's heparin assay was noted to be 0.32.The patient underwent a heart transplant.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific root cause for the report of difficulty oxygenating could not be conclusively determined through this evaluation.The reported event was unable to be recreated as the device was not returned for evaluation.The eurosets amg (advanced membrane gas) pmp (polymethylpentene) oxygenator, lot # 7559008, will reportedly not be returned for evaluation.The production documentation for amg pmp oxygenator, lot number 7559008, was reviewed by the external manufacturer (eurosets) and showed that all tests made in the production process were compliant with the technical specifications.The eurosets amg pmp instructions for use (ifu) (rev.04) 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.Under the section titled, ¿bypass start¿, the ifu contains a subsection on blood gas monitoring and explains how to adjust the relevant parameters based on the patient¿s blood gas values.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.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
• Manufacturer (Section G): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17074788
• MDR Text Key: 316750368
• Report Number: 3003752502-2023-02388
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 7559008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 109 KG