ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
Report
- Report Number
- 3003752502-2025-00049
- Event Type
- Death
- Date Received
- December 10, 2025
- Date of Event
- January 6, 2025
- Report Date
- January 6, 2026
- Manufacturer
- EUROSETS S.R.L.
- Product Code
- DTZ
- UDI-DI
- 08034013782020
- PMA / PMN Number
- K141492
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE REPORTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE REPORTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE REPORTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
THE BLOOD FLOW WAS 2.8, RPM WAS 4500 AND GAS FLOW RATE SWEEP WAS 4. THE OXYGENATOR INLET AND OUTLET PRESSURES AT THE TIME THE ISSUE OCCURRED WAS 479 AND 158 RESPECTIVELY. THE DELTA P WAS 270. THE ISSUE OCCURRED AT 1630 AND THE INITIATION OF SUPPORT WAS AT 1610. THE DEVICE WAS SAID TO NOT BE RETURNED FOR EVALUATION. THE PATIENT WAS SAID TO NOW BE DECEASED.
IT WAS REPORTED THAT THE PERFUSIONIST RECOGNIZED A POSSIBLE OXYGENATOR THROMBUS AND ELECTED TO CHANGE OUT THE OXYGENATOR. THE DETAILS OF EVENT AND ACTIONS PERFORMED WERE UNCLEAR.
THE ACT WAS 276 SECONDS, POST-ECMO INITIATION AND POST-OXYGENATOR EXCHANGE. THE PATIENT WAS SAID TO NOW BE DECEASED ON (B)(6) 2025 AT 1154. ON (B)(6) 2025, THE PATIENT WAS ADMITTED AND UNDERWENT A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WITH CARDIOVERSION. DURING THE INDUCTION OF ANESTHESIA, THE PATIENT EXPERIENCED CARDIAC ARREST AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT DID NOT ACHIEVE RETURN OF SPONTANEOUS CIRCULATION (ROSC) PRIOR TO INITIATION OF EXTRACORPOREAL SUPPORT. THE EXTRACORPOREAL CARDIOPULMONARY RESUSCITATION (ECPR) WAS INITIATED AT 1618 USING AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT WITH A EUROSET OXYGENATOR (AMG PMP ADULT OXYGENATOR, ABBOTT). NO INITIAL HEPARIN BOLUS WAS ADMINISTERED PRIOR TO CANNULATION; HEPARIN 12,000 UNITS WAS ADMINISTERED AT 1627. AT INITIATION OF ECMO THERAPY, THE CIRCUIT FLOWS WERE STABLE AT APPROXIMATELY 3¿4 L/MIN WITH PUMP SPEEDS OF APPROXIMATELY 4500 RPM. BETWEEN 1629¿1630, A DECREASE IN CIRCUIT FLOW WAS OBSERVED DESPITE NO CHANGE IN PUMP SPEED. BY 1630, FLOWS HAD DECREASED TO 2.8 L/MIN, AND THE PATIENT¿S SPO2 DECREASED TO 92%. CONTINUED LOW FLOW THROUGH THE OXYGENATOR WAS ASSOCIATED WITH FURTHER OXYGEN DESATURATION, WITH SPO2 REACHING 78% AT 1643. ARTERIAL BLOOD GAS RESULTS OBTAINED DURING THIS TIME DEMONSTRATED A CORRESPONDING DECREASE IN PAO2. THE PRESSURE GRADIENT ACROSS THE OXYGENATOR WAS MEASURED AT APPROXIMATELY 270 MMHG. BASED ON THE OBSERVED DECREASE IN CIRCUIT FLOW, INCREASED PRESSURE GRADIENT ACROSS THE OXYGENATOR, AND REDUCED OXYGENATION, THE CLINICAL TEAM DETERMINED THAT AN OXYGENATOR EXCHANGE WAS INDICATED. ECMO SUPPORT WAS TEMPORARILY INTERRUPTED TO PERFORM THE EXCHANGE, WHICH WAS COMPLETED BY THE PERFUSIONIST BETWEEN 1720¿1730. FOLLOWING REPLACEMENT OF THE OXYGENATOR, ECMO CIRCUIT FUNCTION RETURNED TO EXPECTED PERFORMANCE WITH IMPROVED FLOWS AND PATIENT OXYGENATION. AN ACT MEASURED AT 1753 WAS 276 SECONDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2877533 | ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | EUROSETS S.R.L. | US5062 | 010276308 | 08034013782020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Unknown | Death |