BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPEDIEM

    MDR report key: 22979103 · Received September 5, 2025

    Report

    Report Number
    1000312731-2025-00019
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 5, 2025
    Manufacturer
    BELLCO SRL
    Product Code
    QIR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE INVOLVED DEVICE IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE (CARPEDIEM IB7010250). BATTISTA, JENNIFER. ¿CONTINUOUS KIDNEY REPLACEMENT THERAPY WITH CARPEDIEM® OF PREMATURE AND LOW BIRTH WEIGHT NEONATES FROM THE FRENCH REGISTRY.¿ PEDIATRIC NEPHROLOGY, 2025. 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 · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY, THIS CASE SERIES RETROSPECTIVELY ANALYZED CASES OF PRETERM OR LOW BIRTH WEIGHT (LBW) IN FANTS TREATED WITH THE MACHINE IN SIX FRENCH TERTIARY ACADEMIC REFERRAL NEONATAL INTENSIVE CARE UNITS (NICU). PATIENT INCLUSION CRITERIA INCLUDED A BIRTH WEIGHT OF LESS THAN 2.5 KILOGRAMS (KG) OR A GESTATIONAL AGE OF 32 WEEKS AND TREATMENT WITH THE CARDIO-RENAL PEDIATRIC DIALYSIS EMERGENCY MACHINE DUE TO ACUTE KIDNEY INJURY (AKI) BETWEEN (B)(6) 2024. THE MACHINES WERE USED FOR ALL TREATMENTS, AND ONLY CONTINUOUS VENOVENOUS HEMOFILTRATION (CVVH) WITH A CONVECTIVE MODALITY IN POST-DILUTION WAS PERFORMED IN THE COHORT, EXCEPT FOR THREE SESSIONS IN PRE-DILUTION MODE. PATIENT CHARACTERISTICS WERE AGE AT CONTINUOUS KIDNEY REPLACEMENT THERAPY (CKRT) INITIATION (DAYS) 6 [2-12] (1-72), WEIGHT AT CKRT INITIATION (KG) 1.9 [1.5-2.4] (1.3-2.8), AND FLUID OVERLOAD, WHICH WAS OBSERVED IN 29% OF THE PATIENTS, ALL OF WHOM HAD A BIRTH WEIGHT BELOW 2.5 KILOGRAMS. ALL PATIENTS WERE CRITICALLY ILL, REQUIRED INOTROPIC SUPPORT, AND WERE MECHANICALLY VENTILATED. 7 OUT OF 10 NEONATES REQUIRED HIGH OSCILLATORY VENTILATION. ONE NEONATE WAS DIAGNOSED WITH PERIVENTRICULAR LEUKOMALACIA; ONE INFANT HAD BILATERAL SUBENCEPHALIC HEMORRHAGE. ALL NEONATES SURVIVED THE DIALYSIS SESSIONS, AND NONE DIED DURING THE TREATMENT. DEATHS THAT OCCURRED AFTER THE END OF CKRT WERE MAINLY DUE TO MULTI-ORGAN FAILURE OR WITHDRAWAL OF CARE FOR SEVERE BRAIN INJURY. THESE DEATHS OCCURRED AT A MEDIAN OF 6 DAYS (RANGE: 1¿63 DAYS) AFTER CKRT. COMPLICATIONS INCLUDED THROMBOCYTOPENIA, CIRCUIT CLOTTING, INTRAVENTRICULAR HEMORRHAGE, AND HYPOTENSION. THROMBOCYTOPENIA REQUIRING PLATELET TRANSFUSIONS OCCURRED IN ALL PATIENTS AND 64% OF SESSIONS (14 OUT OF 22). AFTER PLATELET TRANSFUSION, ALL NEONATES EXCEPT ONE WERE STILL THROMBOCYTOPENIC AT THE END OF THE SESSION. PLATELET CONSUMPTION WAS NOTED IN TWO-THIRDS OF THE SESSIONS. CIRCUIT CLOTTING OCCURRED IN THREE SESSIONS, DESPITE A MEDIAN HEPARIN DOSE OF 10 INTERNATIONAL UNITS PER KILOGRAM PER HOUR (UI/KG/H) AND ANTI-XA LEVELS IN THE TARGET RANGE. INTRAVENTRICULAR HEMORRHAGE WAS DIAGNOSED IN TWO NEONATES NOT PRESENT BEFORE INITIATING CKRT. INTRADIALYTIC HYPOTENSIVE EPISODES NECESSITATING ACUTE VOLUME REPLACEMENT (BEYOND VASOPRESSANT DOSE MODIFICATION, WHICH WAS NOT RECORDED) DEVELOPED IN 13 OF THE 22 SESSIONS (60%) IN 9 NEONATES. HYPOTENSIVE EPISODES WERE ATTRIBUTED TO FLUID REMOVAL, UNDERLYING DISEASE CONDITIONS, AND HEMODYNAMIC INSTABILITY. HYPOKALEMIA (<(><<)> 3.5 MILLIMOLES PER LITER [MMOL/L]) WAS OBSERVED IN 5 OUT OF 22 SESSIONS, WITH THE LOWEST RECORDED VALUE OF 2.8 MMOL/L. HYPOPHOSPHATEMIA WAS ALSO REPORTED, AND PHOSPHATE SUPPLEMENTATION WAS NEEDED. THE DATA SUGGESTED THAT CKRT IN LBW NEONATES WAS TECHNICALLY FEASIBLE BUT POSED CONSIDERABLE CHALLENGES RELATED TO THE RISK OF HYPOTENSIVE EPISODES AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237123 CARPEDIEM PEDIATRIC HEMODIALYSIS SYSTEM QIR BELLCO SRL UNKNOWN RENAL CARE PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Unknown