STANDALONE PMP NEONATAL OXYGENATOR
Report
- Report Number
- 3003752502-2024-00025
- Event Type
- Malfunction
- Date Received
- August 15, 2024
- Date of Event
- July 29, 2024
- Report Date
- January 6, 2025
- Manufacturer
- EUROSETS S.R.L.
- Product Code
- DTZ
- UDI-DI
- 08034013782020
- PMA / PMN Number
- K202510
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: FUNCTIONAL TESTING OF THE RETURNED OXYGENATOR WAS UNABLE TO CONFIRM THE REPORTED BLOOD LEAK, AND A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT WAS BEING TRANSPORTED AFTER APPROXIMATELY 3 DAYS WHEN PINK-TINGED DROPS OF FLUID WERE NOTED TO BE DRIPPING FROM THE GAS EXHAUST PORT. PUMP SPEED WAS 3600 REVOLUTIONS PER MINUTE (RPM) AT THE TIME OF THE EVENT WITH FLOW OF 0.9 LITERS PER MINUTE (LPM). PRE-OXYGENATOR PRESSURE WAS 180 AND POST-OXYGENATOR PRESSURE WAS 165. THE OXYGENATOR WAS REPLACED, WHICH RESOLVED THE ISSUE. THE PRODUCTION DOCUMENTATION FOR EUROSETS PEDIATRIC OXYGENATOR, LOT #9988700, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. DEVICES ARE REQUIRED TO PASS MANUFACTURING INSPECTIONS AND SPECIFICATIONS PRIOR TO RELEASE AND NO ABNORMALITIES WERE DOCUMENTED WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED OCCURRENCE; THIS DEVICE PASSED ALL REQUIRED TESTING. THE OXYGENATOR WAS RETURNED TO ABBOTT, WHERE INITIAL VISUAL INSPECTION FOUND NO ABNORMALITIES, CRACKS, OR DAMAGE TO THE EXTERNAL HOUSING, PORTS, OR FIBERS. THE RETURNED OXYGENATOR WAS PLACED IN A MOCK LOOP WITH SALINE USING A TEST CENTRIMAG PUMP AND EQUIPMENT. NO LEAKING WAS OBSERVED AT PUMP SPEED OF 3600 RPM AND FLOW OF 0.88 LPM. PUMP SPEED WAS INCREASED TO 4500 RPM WITH FLOW OF 2.0 LPM THEN 1.0 LPM; HOWEVER, LEAKING WAS UNABLE TO BE REPLICATED. BASED ON THE TECHNICAL INVESTIGATION, NO ISSUE WAS ABLE TO BE IDENTIFIED. THE OXYGENATOR MANUFACTURER (EUROSETS) COMMUNICATED THAT SIMILAR EVENTS WILL BE MONITORED WITHIN THE EUROSETS TREND REPORTING, AND IN CASE OF ADVERSE TRENDS, FURTHER INVESTIGATION AND/OR CORRECTIVE ACTIONS WILL BE CARRIED OUT. ALTHOUGH LEAKING WAS UNABLE TO BE CONFIRMED THROUGH THIS EVALUATION, ADDITIONAL INVESTIGATION OF OXYGENATOR LEAKING ISSUES HAS BEEN INITIATED BY ABBOTT AND SENT TO EUROSETS (OXYGENATOR SUPPLIER/MANUFACTURER) THROUGH A SUPPLIER CORRECTIVE ACTION REQUEST. THE PRODUCTION DOCUMENTATION FOR THE EUROSETS PEDIATRIC OXYGENATOR, LOT #9988700, 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 PEDIATRIC INSTRUCTIONS FOR USE (IFU), REV. 00, IS CURRENTLY AVAILABLE. UNDER "RISKS AND SIDE EFFECTS," THE IFU LISTS POSSIBLE RISKS AND SIDE EFFECTS, INCLUDING BLOOD LEAKAGE CAUSED BY MECHANICAL FAILURE (E.G. LOSS OF MECHANICAL INTEGRITY). THESE ARE POTENTIAL SIDE EFFECTS OF ALL EXTRACORPOREAL BLOOD CIRCULATION SYSTEMS. UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING USE, A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE AND ALSO WARNS THAT THE DEVICE HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED BY QUALIFIED HEALTHCARE PROFESSIONALS THROUGHOUT THE PROCEDURE. THE IFU WARNS TO CAREFULLY CHECK THE DEVICE SEAL DURING PRIMING AND OPERATION. IF YOU NOTICE LEAKAGE DURING PRIMING OR OPERATION, REPLACE THE DEFECTIVE DEVICE FOLLOWING GOOD PERFUSION PRACTICES. ALSO, UNDER THE SECTION TITLED "SET UP", THE IFU WARNS TO "CARRY OUT A VISUAL INSPECTION AND CAREFULLY CHECK THE DEVICE BEFORE USE. TRANSPORT AND/OR STORAGE CONDITIONS OTHER THAN THOSE PRESCRIBED MAY HAVE CAUSED DAMAGE TO THE DEVICE." UNDER THE SECTION TITLED "DURING BYPASS", THE IFU INSTRUCTS THAT DURING THE ENTIRE PROCEDURE, ACCORDING TO GOOD PREFUSION PRACTICES, MONITOR THE INTEGRITY OF THE SYSTEM FOR LEAKS ABSENCE. IN THIS SECTION, THE IFU WARNS THAT ¿DURING CPB (CARDIOPULMONARY BYPASS) CHECK THE OXYGENATOR INTEGRITY, A SMALL BREACH CAN ALSO RESULT IN CONTINUOUS BLOOD LOSS, BACTERIAL RISK, VIRAL INFECTION OR PYROGEN REACTION. A LARGE BREACH CAN RESULT IN RAPID BLOOD LOSS LEADING TO SHOCK AND DEATH. IF LEAKAGE OCCURS REPLACE THE OXYGENATOR WITH A NEW ONE." 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.
IT WAS REPORTED THAT A PEDIATRIC EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PATIENT WAS BEING TRANSPORTED ON CENTRIMAG AND PEDIATRIC OXYGENATOR SUPPORT. ONCE THE PATIENT ARRIVED, THE CLINICIAN NOTICED PINK FOAM EXITING FROM THE VENT PORT. THE EUROSETS PEDIATRIC OXYGENATOR WAS REPLACED AND THE ISSUE RESOLVED. THE PATIENT WAS NOT IMPACTED BY THE EVENT.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPEED WAS 3600 RPM AND THE FLOW WAS 0.9 LPM. THE PRE-OXYGENATOR PRESSURE WAS 180 AND THE POST-OXYGENATOR PRESSURE WAS 165. THE PATIENT HAD BEEN ON ECMO ABOUT THREE DAYS PRIOR TO THE PATIENT BEING TRANSPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1176870 | STANDALONE PMP NEONATAL OXYGENATOR | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | EUROSETS S.R.L. | US5088 | 600258607 | 08034013782020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 MO | Female |