CARPEDIEM

Description of Event or Problem

ACCORDING TO THE LITERATURE SOURCE OF STUDY, IT PERFORMED A RETROSPECTIVE COHORT ANALYSIS COMPARING PATIENT SEVERITY OF ILLNESS AND OUTCOMES BETWEEN THE PPCRRT AND CARPEDIEM REGISTRIES, INVOLVING 6 ITALIAN PEDIATRIC INTENSIVE CARE UNITS. THE STUDY COMPARED PATIENT OUTCOMES WITH A WEIGHT-MATCHED COHORT (<(><<)> 5 KG) OF 34 PATIENTS FROM THE MULTICENTER ITALIAN REGISTRY OF THE CARPEDIEM USING EITHER CVVH OR CVVHD AND 48 PATIENTS FROM THE PPCRRT REGISTRY. DATA WERE EXTRACTED DATA FROM THE ITALIAN CARPEDIEM REGISTRY AND SUBJECTS WHO WERE <(><<)> 10 KG IN BODY WEIGHT AT THE TIME OF ICU ADMISSION, OR IF CKRT WAS PROVIDED OUTSIDE THE ICU (N = 2), AT THE TIME OF HOSPITAL ADMISSION WERE ASSESSED. SURVIVAL RATES WERE HIGHER FOR THE CARPEDIEM GROUP IN THE RESTRICTED PRIMARY DISEASE GROUP OF FIVE PRIMARY DISEASES (P <(><<)> 0.0001). SUBJECTS WHO DID NOT SURVIVE TO ICU DISCHARGE HAD A HIGHER SEVERITY OF ILLNESS COMPARED TO SURVIVORS IN THE CARPEDIEM COHORT. FOR CARPEDIEM, IT WAS STATED THAT 33/34 SUBJECTS SURVIVED TO CKRT TERMINATION AND 17/34 SURVIVED TO ICU DISCHARGE. REVIEW OF THE CAUSES OF DEATH AND THEIR OBSERVATIONS THAT PATIENTS WHO DID NOT SURVIVE FROM CKRT DISCONTINUATION TO ICU DISCHARGE RECEIVED AT LEAST TWO TREATMENTS WITH THE CARPEDIEM AND DIED AT LEAST 2 DAYS AFTER CKRT DISCONTINUATION. IT WAS SUGGESTED, THEREFORE, THAT UNDERLYING ILLNESS AND OTHER NON-AKI, NON-CKRT-RELATED FACTORS INFLUENCED ICU SURVIVAL. SURVIVAL OF INFANTS TREATED WITH CKRT: COMPARING ADAPTED ADULT PLATFORMS WITH THE CARPEDIEM: STUART L. GOLDSTEIN, 2021, PEDIATRIC NEPHROLOGY

Additional Manufacturer Narrative

THE CARPEDIEM SYSTEM WAS GRANTED DE NOVO CLASSIFICATION BY THE US FDA ON (B)(6), 2020 AND HAS BEEN CLASSIFIED AS CLASS II. AS SUCH, THE CARPEDIEM SYSTEM IS SUBJECT TO MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR 803). SINCE (B)(6), 2020, 5 (FIVE) COMPLAINTS WERE REGISTERED IN THE EU REGION. THESE EVENTS WERE APPROPRIATELY REPORTED TO THE RELEVANT COMPETENT AUTHORITIES WITHIN EU, IN COMPLIANCE WITH LOCAL VIGILANCE REQUIREMENTS. THE SAME EVENTS WERE NOT REPORTED TO THE US FDA, DUE TO AN INITIAL MISCLASSIFICATION OF THE DEVICE WITHIN THE COMPLAINT HANDLING SYSTEM. SPECIFICALLY, THE CARPEDIEM SYSTEM INVOLVED IN THE ABOVE-MENTIONED EVENTS WAS NOT IDENTIFIED AS A "SIMILAR DEVICE" TO THE ONE DISTRIBUTED IN THE US MARKET. THIS CLASSIFICATION ERROR LED TO THE ASSUMPTION THAT THE EVENTS WERE NOT REPORTABLE UNDER FDA¿S MEDICAL DEVICE REPORTING REQUIREMENTS, AND THE EVENTS WERE NOT REPORTED TO THE US FDA. MOZARC MEDICAL WILL, GOING FORTH AND RETROSPECTIVELY, COMPLY WITH ALL FD <(>&<)>C ACT'S REQUIREMENTS INCLUDING MEDICAL DEVICE REPORTING (21 CFR 803) FOR THE CARPEDIEM SYSTEM. SURVIVAL OF INFANTS TREATED WITH CKRT: COMPARING ADAPTED ADULT PLATFORMS WITH THE CARPEDIEM: STUART L. GOLDSTEIN, 2021, PEDIATRIC NEPHROLOGY MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.