BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RENAL CARE PRODUCT

    MDR report key: 23446102 · Received November 3, 2025

    Report

    Report Number
    1000312731-2025-00020
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 1, 2025
    Manufacturer
    BELLCO SRL
    Product Code
    QIR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFANT RENAL REPLACEMENT THERAPY USING CARPEDIEM: A MULTICENTER OBSERVATIONAL COHORT STUDY FROM THE ICONIIC LEARNING NETWORK D10 - CONCOMITANT PRODUCT: UNKNOWN, UNKNOWN RENAL CARE PRODUCT SN: UNKNOWN. 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, A MULTICENTER, PROSPECTIVE, OBSERVATIONAL LEARNING STUDY FOCUSED ON 67 INFANTS RECEIVING RRT (RENAL REPLACEMENT THERAPY). 13 PATIENTS WEIGHED LESS THAN 2.5 KG (KILOGRAMS) (20%), AND THE SMALLEST WAS REPORTED TO BE 1.5 KG. 64 PATIENTS WITH 92 TREATMENT COURSES WITH MAJOR COMPLICATIONS REPORTED IN 26 PATIENTS; SEPSIS/BACTEREMIA (N (NUMBER) =9) AND NEW OR WORSENING INTRACRANIAL/IVH (INTRAVENTRICULAR HEMORRHAGE) (N=9) WERE THE MOST FREQUENT. COMPLICATIONS OCCURRED IN 15 (42%) PATIENTS IN THE ESKD (END-STAGE KIDNEY DISEASE) COHORT WITH NEW OR WORSENING IVH (N=7) AND SEPSIS/BACTEREMIA (N=6). SURVIVAL TO HOSPITAL DISCHARGE WAS 67% (N=22). 11 DID NOT SURVIVE, AND THE MOST COMMON CAUSE OF DEATH WAS PULMONARY HYPOPLASIA. MAJOR COMPLICATIONS (N=12) OCCURRED IN 11 PATIENTS IN THE NON-ESKD COHORT, WHICH INCLUDED THROMBOTIC EVENTS RELATED TO THE DIALYSIS CATHETER (N=5), SEPSIS/BACTEREMIA (N=3), AND GASTROINTESTINAL BLEEDING (NON-NEC RELATED) (N=3). THE MOST COMMON CAUSE OF DEATH WAS SEPSIS/INFECTION (N=6). ALMOST HALF THE PATIENTS IN OUR COHORT RECEIVED CRRT FOR ESKD AS A BRIDGE TO PD (PERITONEAL DIALYSIS). ADDITIONAL CHALLENGES WITH THE MACHINE INCLUDE THAT THE COMMERCIALLY AVAILABLE DIALYSIS/REPLACEMENT FLUID CONTAINED CALCIUM (1.5 MMOL/L (MILLIMOLES PER LITER)) AND A BICARBONATE CONCENTRATION OF 32 MEQ/L (MILLIEQUIVALENTS PER LITER). THUS, IT NECESSITATES TRADITIONAL PROTOCOL MODIFICATIONS, WHICH WERE DESIGNED FOR CALCIUM-FREE FLUIDS, ALONG WITH ALKALOSIS MONITORING. THE NON-ESKD COHORT WAS VERY HETEROGENEOUS, WITH PATIENTS HAVING VARIABLE UNDERLYING CONDITIONS THAT COULD HAVE AFFECTED THEIR OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797947 UNKNOWN RENAL CARE PRODUCT PEDIATRIC HEMODIALYSIS SYSTEM QIR BELLCO SRL UNKNOWN RENAL CARE PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NOTES.