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

Model Number US5062

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 05/23/2020

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 amg oxygenator clotted.The patient returned to the operating room to reposition cannulae.The amg oxygenator was replaced with a quadrox.

Event Description

It was reported the patient was symptomatic but not injured during the event.

Manufacturer Narrative

Section d4, h5, h8: correction.Section a2, a3, a4, h4: additional information.Manufacturer's investigation conclusion: the evaluation of the returned device confirmed the report that the oxygenator clotted.The eurosets amg pmp oxygenator, lot number 6136406, 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 eurosets for technical analysis.Following washing and sterilization, a functional test was performed.The pressure drops measured across the oxygenator during the test were found to be greater than the technical specifications.Examination of the polymethylpentene (pmp) fibers showed that they were partially clotted with evidence of red clots.Clotting of the pmp membrane during patient support could result in a drop in partial pressure of oxygen (po2) levels.A specific cause for the observed clotting could not be conclusively determined and could not be correlated to a device-related issue.However, the reported information indicated that the partial thromboplastin time (ptt) during patient support ranged from 45-60 seconds.Based on international guidelines, the manufacturer suggests maintaining a ptt range of around 61-75 seconds.The eurosets amg pmp instructions for use (ifu) is currently available.The production documentation for amg pmp oxygenator, lot number 6136406, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.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 "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: 10180058
• MDR Text Key: 196055316
• Report Number: 2916596-2020-03238
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 6136406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• 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: 78 YR
• Patient Weight: 69