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

Model Number US5062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Inflammation (1932); Septic Shock (2068); Jaundice (2187); Lactate Dehydrogenase Increased (4567)

Event Date 10/04/2020

Event Type  Injury  

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 doctor was concern that the oxygenator caused severe hemolysis and inflammation.The patient had an hm3 implanted on (b)(6) 2020 with a protek duo/lifesparc inserted later in the day (b)(6) 2020 along with amg/pmp oxygenator.Oxygenator was changed out on (b)(6) 2020 when ldh (lactate dehydrogenase) was noted to be 3190.Ldh remained elevated and oxygenator was discontinued on (b)(6) 2020 at 5 pm.Ldh on (b)(6) 2020 was 2030 and (b)(6) 2020 1500.Patient remains on protek and lifesparc on the right side with hm3 on the left.

Manufacturer Narrative

Section d4: correction; 5836706 was originally listed as the serial number on the previous report but it the lot number of the device.

Event Description

The site communicated that the ldh started to rise again after the discontinuation of the oxygenator and the patient became jaundiced and septic.They have since placed patient on centrally cannulated va ecmo with centrimag and amg/pmp.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the returned device confirmed evidence of clotting.The eurosets amg pmp oxygenator, lot number 5836706, was returned to an abbott facility in burlington, ma, where an initial visual inspection was performed.The device was returned filled with blood.A section of tubing was connected between the blood inlet port and the blood outlet port.Visual inspection of the oxygenator revealed no obvious damage or anomalies to the external housing, ports, or fibers.There were no observations related to the reported event.The amg pmp oxygenator was forwarded to the external manufacturer (eurosets) for technical analysis.When attempting to wash the device, a flow of only 0.5 liters per minute (lpm) could be established through the oxygenator.Moreover, an inlet pressure of 700 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 or gas analysis.The heat exchanger was removed, and clots were observed on both the blood in and blood out components of the exchanger.The production documentation for amg pmp oxygenator, lot number 5836706, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.Although a specific cause for the observed clotting could not be conclusively determined and could not be directly correlated to the device, clotting of the blood pathway would have contributed to the reported hemolysis.The patient became jaundiced and septic, and eventually expired on (b)(6) 2020 (captured under mfr.Report # 2916596-2020-05075).The eurosets amg pmp instructions for use (ifu) rev.04, is currently available.Under the section titled, ¿intended use¿, the ifu states that the ¿a.M.G.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¿ and also that the device ¿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 and also wants that the extracorporeal circulation has to be carefully and continuously checked.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.This section also contains a subsection on blood gas monitoring and explains how to adjust the relevant parameters based on the patient¿s blood gas values.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 ¿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
• MDR Report Key: 10719029
• MDR Text Key: 216866248
• Report Number: 3003752502-2020-04150
• 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,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 5836706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 144