ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
Report
- Report Number
- 3003752502-2024-00026
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- August 6, 2024
- Report Date
- December 20, 2024
- Manufacturer
- EUROSETS S.R.L.
- Product Code
- DTZ
- PMA / PMN Number
- K141492
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTION D4: EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
MANUFACTURER'S INVESTIGATION CONCLUSION: BLOOD LEAKAGE FROM THE DEVICE WAS CONFIRMED THROUGH THE SUBMITTED IMAGE AND RETURNED DEVICE; HOWEVER, BASED ON THE CONDITION OF THE RETURNED DEVICE, EUROSETS (THE EXTERNAL MANUFACTURER) WAS UNABLE TO CARRY OUT THE TECHNICAL INVESTIGATION TO IDENTIFY THE ROOT CAUSE OF THE PROBLEM. EVALUATION OF THE SUBMITTED IMAGE CONFIRMED THAT BLOOD WAS LEAKING FROM THE OXYGENATOR. THE BLOOD APPEARED TO BE DRIPPING FROM THE BOTTOM OF THE ORANGE HOUSING. THE OXYGENATOR WAS RETURNED TO ABBOTT WHERE AN INITIAL VISUAL INSPECTION WAS PERFORMED. VISUAL INSPECTION OF THE OXYGENATOR REVEALED NO OBVIOUS DAMAGE; HOWEVER, DRIED BLOOD WAS NOTED IN THE BOTTOM ORANGE HOUSING, WITHIN THE GAS FLOW PATHWAY. THE OXYGENATOR WAS FORWARDED TO THE EXTERNAL MANUFACTURER (EUROSETS) FOR TECHNICAL ANALYSIS; HOWEVER, BASED ON THE CONDITION OF THE RETURNED DEVICE, EUROSETS WAS UNABLE TO CARRY OUT THE TECHNICAL INVESTIGATION TO IDENTIFY THE ROOT CAUSE OF THE PROBLEM. THE PRODUCTION DOCUMENTATION FOR EUROSETS AMG PMP OXYGENATOR, LOT # 9740808, 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. 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 AMG PMP OXYGENATOR, LOT #9740808, 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 INSTRUCTIONS FOR USE (IFU), REV. 05, 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. 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.
B5: NARRATIVE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
IT WAS REPORTED THAT THERE WAS RED BLOOD LEAKING FROM THE BOTTOM OF THE OXYGENATOR. ALL CONNECTIONS WERE CONFIRMED TO HAVE BEEN SECURE. THE OXYGENATOR WAS CHANGED OUT WITHOUT EVENT.
THE OXYGENATOR HAD BEEN IN USE FOR ABOUT 22 HOUR BEFORE THE ISSUE WAS IDENTIFIED AND THERE WERE NO ISSUES NOTED DURING PRIMING OF THE OXYGENATOR. THE FLOWS WERE RANGING FROM 5.5 TO 5.7 LPM AND NO PRESSURES WERE RECORDED. 0.08 ANTIXA WAS USED AND THE PARTIAL THROMBOPLASTIN TIME (PTT) WAS 69.8 SECONDS. IT WAS NOTED THAT IT WAS UNLIKELY THE PRODUCT WAS CONTAMINATED WITH BIOLOGICAL RESIDUE OF WHO RISK GROUP 1, 2, 3, OR 4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 969589 | ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | EUROSETS S.R.L. | US5062 | 09740808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Male |