ULTRAFLUX EMIC2
Report
- Report Number
- 3002807005-2023-00029
- Event Type
- Injury
- Date Received
- July 6, 2023
- Date of Event
- June 26, 2023
- Report Date
- October 19, 2023
- Manufacturer
- ST. WENDEL AG
- Product Code
- FJK
- PMA / PMN Number
- EUA200149
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CVVHD UTILIZING THE ULTRAFLUX EMIC2 FILTER, AND THE SERIOUS ADVERSE EVENT OF DIC. THE PATIENT WAS ADMITTED FOR A PARACETAMOL OVERDOSE (CHARACTERIZED BY ALF) AND WAS BEING TREATED WITH CVVHD WHEN THE DIC BEGAN. GIVEN THE PATIENT¿S POSITIVE RESPONSE TO THE DISCONTINUATION OF THERAPY (RESOLUTION OF DIC), THE DOCUMENTATION PROVIDED INDICATES THE ULTRAFLUX EMIC2 WAS CITED AS THE POTENTIAL CAUSE OF THE SERIOUS ADVERSE EVENT. THEREFORE, BASED ON THE TOTALITY OF THE INFORMATION AVAILABLE, THE ULTRAFLUX EMIC2 CANNOT BE EXCLUDED FROM HAVING A POSSIBLE CAUSAL OR CONTRIBUTORY ROLE IN THE PATIENT¿S SERIOUS ADVERSE EVENT. DESPITE THERE BEING NO OBSERVED/REPORTED MANUFACTURING DEFECT(S); MINIMAL ACCESS TO THE PATIENT¿S HOSPITAL RECORDS, TREATMENT RECORDS, OR FURTHER EVALUATION OF THE SUSPECT PRODUCT(S), PREVENTED THIS CLINICAL INVESTIGATION FROM DISASSOCIATING THE ULTRAFLUX EMIC2 FROM THE SERIOUS ADVERSE EVENT.
CORRECTION PROVIDED IN D4.
PLANT INVESTIGATION: THE CAUSE FOR THE FAILURE REPORTED CANNOT BE CONFIRMED BASED ON THE CURRENT AVAILABLE INFORMATION. THE EXTRACTION OF RETAINED SAMPLES SHOWED NO UNUSUAL RESIDUALS WHICH COULD LEAD TO THE REPORTED SITUATION. ADDITIONALLY FURTHER UNUSED SAMPLES OF THE COMPLAINED BATCH WERE INSPECTED ACCORDING TO THE INSPECTION PROTOCOL FOR SIEVING COEFFICIENT AND WERE FOUND CONFORMING TO RELEASE SPECIFICATIONS. THEREFORE, IT IS ASSUMED THAT THE COMPLAINED SITUATION OF THE PATIENT MIGHT BE CAUSED BY OTHER FACTORS BESIDES THE SUSPECTED DIALYZER, FOR EXAMPLE, THE SPECIFIC PHYSICAL/MEDICAL STATUS OF PATIENT OR THE LONG TREATMENT WITHOUT ANTICOAGULATION. ANTICOAGULATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU) AND MONITORING FOR IT IS RECOMMENDED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. THE BATCH RECORDS WERE REVIEWED. 7620 PRODUCTS HAVE BEEN INSPECTED ACCORDING TO THE INSPECTION PROTOCOL AND WERE FOUND CONFORMING TO SPECIFICATIONS. NO INDICATION FOR ANY RELATIONSHIP WITH THE REPORTED FAILURE MODE HAS BEEN FOUND DURING THE REVIEW.
ON (B)(6) 2023, FRESENIUS BECAME AWARE A PATIENT WITH ACUTE LIVER FAILURE (ALF) AND ACUTE KIDNEY INJURY (AKI) ON CONTINUOUS VENOVENOUS HEMODIALYSIS (CVVHD) IN THE INTENSIVE CARE UNIT (ICU) EXPERIENCED LIFE THREATENING DISSEMINATED INTRAVASCULAR COAGULATION (DATES NOT PROVIDED). RECORDS REVEALED THE PATIENT PRESENTED TO THE HOSPITAL WITH ALF, DERANGED CLOTTING, INCREASED DEXTROSE REQUIREMENT, AND SHOCK FOLLOWING A PARACETAMOL OVERDOSE. UPON ARRIVAL AT THE ICU, THE PATIENT WAS INTUBATED AND STARTED ON CVVHD, UTILIZING THE ULTRAFLUX EMIC2 FILTER (ANTICOAGULANT FREE). THE PATIENT BEGAN SHOWING SIGNS OF IMPROVEMENT, HOWEVER ON DAY 10 OF CVVHD (NO ALARMS PRESENT) THE PATIENT DEVELOPED LIFE THREATENING DIC (FROM ORAL CAVITY AND LINE/CATHETER SITES) WITH UNRECORDABILITY LOW FIBRINOGEN AND PLATELETS. THE PATIENT¿S D-DIMER WAS 17,600 NG/ML AND NO ANTICOAGULATION WAS ADMINISTERED BEFORE OR DURING THE DIC EVENT. THE DIC LASTED FOR APPROXIMATELY 4 DAYS, REQUIRING LARGE VOLUMES OF FRESH FROZEN PLASMA (FFP), FIBRINOGEN CONCENTRATE, AND PLATELETS. THE CAUSE OF DIC COULD NOT BE DETERMINED (NO SIGNS OF SEPSIS, PANCREATITIS, OR CAUSATIVE DRUG), THE PATIENTS¿ CVVHD WAS STOPPED (NO PLASMA EXCHANGE PROVIDED) AND THE PATIENT QUICKLY IMPROVED (I.E., SHOCK RESOLVED, FALLING AMMONIA LEVEL, NORMALIZATION OF COAGULATION PROFILE, NO LONGER REQUIRED SUPPLEMENTAL DEXTROSE, ALF IMPROVING). THE CAUSE OF DIC COULD NOT BE DETERMINED (NO SIGNS OF SEPSIS, PANCREATITIS, OR CAUSATIVE DRUG); THEREFORE, CVVHD WAS NOT RESTARTED AND THE CAUSE OF THE DIC WAS PRESUMED TO BE THE EMIC2 FILTER. THE REPORTING CLINICIAN INDICATES THE HOSPITALS¿ STANDARD OF CARE FOR TREATING PATIENTS WITH RHABDOMYOLYSIS, SEPTICEMIA AND ALF WAS INSTITUTED, AND INCLUDED CVVHD UTILIZING HOURLY 4.8-LITER VOLUME EXCHANGES, ULTRAFILTRATION = 100 ML/HOUR, AND A BLOOD FLOW RATE OF 250-350 ML. ADDITIONALLY, THE PATIENT WAS RECEIVING PROPOFOL, ALFENTANIL, MEROPENEM AND ANIDULAFUNGIN (DESPITE NO POSITIVE MICRO/INFECTION MARKERS). THE PATIENT¿S CURRENT DISPOSITION IS UNKNOWN.
ON 26/JUN/2023, FRESENIUS BECAME AWARE A PATIENT WITH ACUTE LIVER FAILURE (ALF) AND ACUTE KIDNEY INJURY (AKI) ON CONTINUOUS VENOVENUS HEMODIALYSIS (CVVHD) IN THE INTENSIVE CARE UNIT (ICU) EXPERIENCED LIFE THREATENING DISSEMINATED INTRAVASCULAR COAGULATION (DATES NOT PROVIDED). RECORDS REVEALED THE PATIENT PRESENTED TO THE HOSPITAL WITH ALF, DERANGED CLOTTING, INCREASED DEXTROSE REQUIREMENT, AND SHOCK FOLLOWING A PARACETAMOL OVERDOSE. UPON ARRIVAL AT THE ICU, THE PATIENT WAS INTUBATED AND STARTED ON CVVHD, UTILIZING THE ULTRAFLUX EMIC2 FILTER (ANTICOAGULANT FREE). THE PATIENT BEGAN SHOWING SIGNS OF IMPROVEMENT, HOWEVER ON DAY 10 OF CVVHD (NO ALARMS PRESENT) THE PATIENT DEVELOPED LIFE THREATENING DIC (FROM ORAL CAVITY AND LINE/CATHETER SITES) WITH UNRECORDABLY LOW FIBRINOGEN AND PLATELETS. THE PATIENT¿S D-DIMER WAS 17,600 NG/ML AND NO ANTICOAGULATION WAS ADMINISTERED BEFORE OR DURING THE DIC EVENT. THE DIC LASTED FOR APPROXIMATELY 4 DAYS, REQUIRING LARGE VOLUMES OF FRESH FROZEN PLASMA (FFP), FIBRINOGEN CONCENTRATE, AND PLATELETS. THE CAUSE OF DIC COULD NOT BE DETERMINED (NO SIGNS OF SEPSIS, PANCREATITIS, OR CAUSATIVE DRUG), THE PATIENTS¿ CVVHD WAS STOPPED (NO PLASMA EXCHANGE PROVIDED) AND THE PATIENT QUICKLY IMPROVED (I.E., SHOCK RESOLVED, FALLING AMMONIA LEVEL, NORMALIZATION OF COAGULATION PROFILE, NO LONGER REQUIRED SUPPLEMENTAL DEXTROSE, ALF IMPROVING). THE CAUSE OF DIC COULD NOT BE DETERMINED (NO SIGNS OF SEPSIS, PANCREATITIS, OR CAUSATIVE DRUG); THEREFORE, CVVHD WAS NOT RESTARTED AND THE CAUSE OF THE DIC WAS PRESUMED TO BE THE EMIC2 FILTER. THE REPORTING CLINICIAN INDICATES THE HOSPITALS¿ STANDARD OF CARE FOR TREATING PATIENTS WITH RHABDOMYOLYSIS, SEPTICEMIA AND ALF WAS INSTITUTED, AND INCLUDED CVVHD UTILIZING HOURLY 4.8-LITER VOLUME EXCHANGES, ULTRAFILTRATION = 100 ML/HOUR, AND A BLOOD FLOW RATE OF 250-350 ML. ADDITIONALLY, THE PATIENT WAS RECEIVING PROPOFOL, ALFENTANIL, MEROPENEM AND ANIDULAFUNGIN (DESPITE NO POSITIVE MICRO/INFECTION MARKERS). THE PATIENT¿S CURRENT DISPOSITION IS UNKNOWN.
ON (B)(6) 2023, FRESENIUS BECAME AWARE A PATIENT WITH ACUTE LIVER FAILURE (ALF) AND ACUTE KIDNEY INJURY (AKI) ON CONTINUOUS VENOVENUS HEMODIALYSIS (CVVHD) IN THE INTENSIVE CARE UNIT (ICU) EXPERIENCED LIFE THREATENING DISSEMINATED INTRAVASCULAR COAGULATION (DATES NOT PROVIDED). RECORDS REVEALED THE PATIENT PRESENTED TO THE HOSPITAL WITH ALF, DERANGED CLOTTING, INCREASED DEXTROSE REQUIREMENT, AND SHOCK FOLLOWING A PARACETAMOL OVERDOSE. UPON ARRIVAL AT THE ICU, THE PATIENT WAS INTUBATED AND STARTED ON CVVHD, UTILIZING THE ULTRAFLUX EMIC2 FILTER (ANTICOAGULANT FREE). THE PATIENT BEGAN SHOWING SIGNS OF IMPROVEMENT, HOWEVER ON DAY 10 OF CVVHD (NO ALARMS PRESENT) THE PATIENT DEVELOPED LIFE THREATENING DIC (FROM ORAL CAVITY AND LINE/CATHETER SITES) WITH UNRECORDABLY LOW FIBRINOGEN AND PLATELETS. THE PATIENT¿S D-DIMER WAS 17,600 NG/ML AND NO ANTICOAGULATION WAS ADMINISTERED BEFORE OR DURING THE DIC EVENT. THE DIC LASTED FOR APPROXIMATELY 4 DAYS, REQUIRING LARGE VOLUMES OF FRESH FROZEN PLASMA (FFP), FIBRINOGEN CONCENTRATE, AND PLATELETS. THE CAUSE OF DIC COULD NOT BE DETERMINED (NO SIGNS OF SEPSIS, PANCREATITIS, OR CAUSATIVE DRUG), THE PATIENTS¿ CVVHD WAS STOPPED (NO PLASMA EXCHANGE PROVIDED) AND THE PATIENT QUICKLY IMPROVED (I.E., SHOCK RESOLVED, FALLING AMMONIA LEVEL, NORMALIZATION OF COAGULATION PROFILE, NO LONGER REQUIRED SUPPLEMENTAL DEXTROSE, ALF IMPROVING). THE CAUSE OF DIC COULD NOT BE DETERMINED (NO SIGNS OF SEPSIS, PANCREATITIS, OR CAUSATIVE DRUG); THEREFORE, CVVHD WAS NOT RESTARTED AND THE CAUSE OF THE DIC WAS PRESUMED TO BE THE EMIC2 FILTER. THE REPORTING CLINICIAN INDICATES THE HOSPITALS¿ STANDARD OF CARE FOR TREATING PATIENTS WITH RHABDOMYOLYSIS, SEPTICEMIA AND ALF WAS INSTITUTED, AND INCLUDED CVVHD UTILIZING HOURLY 4.8-LITER VOLUME EXCHANGES, ULTRAFILTRATION = 100 ML/HOUR, AND A BLOOD FLOW RATE OF 250-350 ML. ADDITIONALLY, THE PATIENT WAS RECEIVING PROPOFOL, ALFENTANIL, MEROPENEM AND ANIDULAFUNGIN (DESPITE NO POSITIVE MICRO/INFECTION MARKERS). THE PATIENT¿S CURRENT DISPOSITION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1911400 | ULTRAFLUX EMIC2 | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | FJK | ST. WENDEL AG | D2BC03100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Male | Required Intervention| H | MULTIBIC K4.| MULTIBIC K4.| MULTIBIC K4.| MULTIFILTRATEPRO MACHINE.| MULTIFILTRATEPRO MACHINE.| MULTIFILTRATEPRO MACHINE. |