CARPEDIEM

Additional Manufacturer Narrative

THE CARPEDIEM SYSTEM WAS GRANTED DE NOVO CLASSIFICATION BY THE US FDA ON APRIL 29, 2020, AND HAS BEEN CLASSIFIED AS CLASS II. AS SUCH, THE CARPEDIEM SYSTEM IS SUBJECT TO MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR 803). SINCE APRIL 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 FDC ACT'S REQUIREMENTS INCLUDING MEDICAL DEVICE REPORTING (21 CFR 803) FOR THE CARPEDIEM SYSTEM. D10 - CONCOMITANT PRODUCT: IB7010200, EQ IB7010200 CARPEDIEM, SN: UNKNOWN CARPEDIEM R FOR CONTINUOUS KIDNEY REPLACEMENT THERAPY IN NEONATES AND SMALL INFANTS: A FRENCH MULTICENTER RETROSPECTIVE STUDY, (B)(6), 2022, 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.

Description of Event or Problem

PLI 10: ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY FROM 2018 TO 2022 ASSESSED THE EFFECTIVENESS, FEASIBILITY, OUTCOMES, AND TECHNICAL CONSIDERATIONS OF CARPEDIEM USE IN 19 NEWBORNS AND SIX INFANTS. ALL THE PATIENTS SURVIVED THE SESSIONS, BUT ONLY 8 PATIENTS WERE ALIVE AT HOSPITAL DISCHARGE AS 17 PATIENTS DIED FROM THEIR PRIMARY SEVERE DISEASE. PLI 20: ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY FROM 2018 TO 2022 ASSESSED THE EFFECTIVENESS, FEASIBILITY, OUTCOMES, AND TECHNICAL CONSIDERATIONS OF CARPEDIEM USE IN 19 NEWBORNS AND SIX INFANTS. UF (ULTRAFILTRATION) WAS STOPPED MOMENTARILY DUE TO HEMODYNAMIC INSTABILITY (REFERRED TO HYPOTENSION LOWER THAN GESTATIONAL AGE FOR NEONATES AND LOWER THAN 50 MMHG FOR INFANTS). CLOTTING, PRESSURE DYSFUNCTION DUE TO MACHINE PRESSURE POD ISSUES AND RESTITUTION FAILURE WERE OBSERVED. FOR THE PATIENT WEIGHING 11 KG, THE MACHINE WAS USED BECAUSE THE CONVENTIONAL DEVICE WAS NOT AVAILABLE (OFF LABEL). CIRCUITS WERE ANTICOAGULATED USING HEPARIN AND WERE PRIMED. HBIOFLUIDS+ (COMPANY BRAND) CONTAINING 32 MMOL/L OF SODIUM BICARBONATE AND 2.5 MMOL/L OF POTASSIUM WAS USED AS REPLACEMENT SOLUTION. FOR CONTINUOUS VENOVENOUS HEMOFILTRATION (CVVH), BLOOD FLOW RATE WAS 8 ML/KG/MIN, EFFLUENT FLOW RATE WAS 74 ML/KG/H AND NET ULTRAFILTRATION (UF) 6 ML/KG/H. FOR HEMODIALYSIS, THE BLOOD AND DIALYSATE FLOW RATES WERE 6 ML/KG/MIN AND 600 ML/H. INFUSION ADMINISTRATION OR VOLUME REPLACEMENT OR WAS PERFORMED WITH FLUID REPLACEMENT (NACL 0.9% NORMAL SALINE, ALBUMIN, PRBC PACKED RED BLOOD CELLS) FOLLOWING LOCAL PROTOCOLS DUE TO HYPOTENSION. THROMBOCYTOPENIA WAS ALSO OBSERVED AND PATIENTS RECEIVED PLATELET TRANSFUSIONS IN ABOUT A FIFTH OF THE SESSIONS. NO HEMORRHAGE OCCURRED. LABORATORY DATA COLLECTION WERE SERUM CREATININE, SERUM POTASSIUM, BLOOD UREA NITROGEN, HEMOGLOBIN, AND PLATELET LEVELS. ALL PATIENTS SURVIVED THE SESSIONS. CARPEDIEM R FOR CONTINUOUS KIDNEY REPLACEMENT THERAPY IN NEONATES AND SMALL INFANTS: A FRENCH MULTICENTER RETROSPECTIVE STUDY, (B)(6), 2022, PEDIATRIC NEPHROLOGY.