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

Model Number US5062

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Abnormal Blood Gases (1034)

Event Date 05/26/2020

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 partial pressure of oxygen (pao2) going on the pump was 300 millimeters of mercury (mm hg) and dropped to 200.The yellow cap on the gas egress was off.It was reported that the patient had a history of end-stage ischemic cardiomyopathy and left ventricular assist device (lvad) support prior to receiving heart transplantation.Post transplant the patient was placed on venous arterial extracorporeal membrane oxygenation (va ecmo) via central cannulation due to post operative pulmonary edema and primary graft dysfunction on (b)(6) 2020.The patient was weaned from va ecmo on (b)(6) 2020 and was proven to be stable.The patient was later returned to the operating room for emergent venous venous extracorporeal membrane oxygenation (vv ecmo) initiation due to cardiogenic shock secondary to right ventricular dysfunction status post heart transplantation and pulmonary hypertension.At this second initiation of ecmo, the oxygenator was used.There were no additional event details available.The patient was in right ventricle failure post heart transplant.The patient was weaned off ecmo after 3 days on support.The patient was put back on ecmo after being off support for 3 days.

Manufacturer Narrative

Incidental findings: eurosets confirmed that the oxygenator was clotted.Manufacturer's investigation conclusion: the evaluation of the returned device confirmed evidence of clotting, which could have contributed to the report of a drop in partial pressure of oxygen (pao2) levels.The eurosets amg pmp oxygenator, lot number 5969906, was returned to abbott and an initial visual inspection was performed.The device was returned filled with blood.Visual inspection of the oxygenator revealed no obvious damage to the external housing, ports, or fibers.No blood was observed within the top or bottom orange housing.The oxygenator was forwarded to the external manufacturer for technical analysis.When attempting to wash the device, a flow of only 1 liter per minute could be established through the oxygenator.Moreover, an inlet pressure of 500 mmhg was detected and the device was determined to be clotted.Because the oxygenator was clotted, the manufacturer could not perform functional testing of the device.The oxygenator was severed to expose a cross section of the internal polymethylpentene (pmp) fibers, which were found to be partially clotted with evidence of red clots.Although a specific cause for the observed clotting could not be conclusively determined and could not be correlated to a device-related issue, clotting of the pmp membrane during patient support could have resulted in the reported drop in pao2 levels.The production documentation for amg pmp oxygenator, lot number 5969906, was reviewed by the external manufacturer 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.The section titled "intended use" explains that the amg module pmp no t.P.Sterile is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.The amg module pmp no t.P.Sterile is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.Contact with blood for a longer period of time is unadvisable.Under the list of warnings, the ifu warns that during the extracorporeal circulation (ecc) a backup oxygenator is necessary.Under the list of precautions, the ifu cautions that a strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures.The benefit of extracorporeal support must be weighed against the risk of systemic anticoagulation and must be assessed by the prescribing physician.Adequate heparinization must be maintained before and during bypass.The "priming and recirculation procedure" section warns to check the correct dosage of anticoagulant in the system before starting the bypass.The "bypass start" section states to check that anticoagulation level (act) is appropriate before starting the procedure.The "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 "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 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.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: 10149878
• MDR Text Key: 196450641
• Report Number: 0002916596-2020-03056
• 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
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 5969906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 84