BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 23216165 · Received October 3, 2025

    Report

    Report Number
    1282497-2025-00598
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    March 25, 2025
    Report Date
    October 6, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IZZET TURKALP, AKBASLI OZLEM, SARITAS NAKIB, SELMAN KESICI, FATMA VISAL OKUR, KADRI SAFAK, GUCER, BENAN BAYRAKCI EVIDENCE OF STEM CELL ENTRAPMENT IN AN69 MEMBRANES DURING CONTINUOUS RENAL REPLACEMENT THERAPY ARTIFICIAL ORGANS, 2025; 49:1327¿1331 HTTPS://DOI.ORG/10.1111/AOR.15004. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H6 ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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 REPORT, A 10-YEAR-OLD PEDIATRIC PATIENT WITH A TWO-YEAR HISTORY OF BONE MARROW FAILURE AND CHRONIC KIDNEY DISEASE DEVELOPED SEPTIC SHOCK IMMEDIATELY AFTER THE CONDITIONING REGIMEN BEFORE THE SCHEDULED ALLO-HSCT (ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION), SUBSEQUENTLY REQUIRING ADMISSION TO THE PICU. THE PATIENT'S SEPSIS AND ACUTE KIDNEY INJURY WERE MANAGED USING CVVHDF (CONTINUOUS VENO-VENOUS HEMODIAFILTRATION) WITH A BIOCOMPATIBLE, HIGH-PERMEABILITY AN69 MEMBRANE AND BROAD-SPECTRUM ANTIMICROBIAL THERAPY, WHILE THE POSTPONED ALLO-HSCT WAS PERFORMED SUCCESSFULLY. VASCULAR ACCESS WAS OBTAINED USING AN 8 FRENCH TEMPORARY DUAL-LUMEN VENOVENOUS HEMODIALYSIS CATHETER (COVIDIEN INC.) INSERTED VIA THE LEFT INTERNAL JUGULAR VEIN BY THE INTENSIVE CARE TEAM.THE PATIENT DEVELOPED NEUTROPENIC FEVER DURING THE FINAL 2 DAYS (ON THE LAST DAY OF ANTI-THYMOCYTE GLOBULIN THERAPY, DAY -1) OF THE REDUCED-INTENSITY CONDITIONING REGIMEN. ESCHERICHIA COLI, SENSITIVE TO ALL ANTIBIOTICS TESTED, WAS CULTURED FROM BOTH BLOOD AND CATHETER SAMPLES, SUGGESTING GASTROINTESTINAL TRANSLOCATION AS THE SOURCE OF INFECTION. DESPITE MEROPENEM TREATMENT IN THE TRANSPLANTATION UNIT, THE PATIENT'S CONDITION PROGRESSED TO MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS), NECESSITATING TRANSFER TO THE PICU FOR ADVANCED CARE. E. COLI SEPSIS WAS CONSIDERED TO BE OF ENTERIC ORIGIN; THEREFORE, THIS WAS NOT A CATHETER-RELATED EVENT. AT THIS CRITICAL JUNCTURE, THE PEDIATRIC BONE MARROW TRANSPLANT TEAM DECIDED TO ADMINISTER THE PREPARED ALLOGENEIC HSCT GRAFT FROM A FULLY MATCHED SIBLING DONOR TO TREAT THE PATIENT'S PRIMARY DISEASE, APLASTIC ANEMIA, WITHOUT FURTHER DELAY. PATIENTS ALSO RECEIVE SPECIFIC IMM UNOSUPPRESSIVE MEDICATIONS FOR GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS. THE INFUSION WAS PERFORMED VIA A CENTRAL VENOUS CATHETER AT THE 20TH HOUR OF CVVHDF. THUS, PATIENTS ARE FOLLOWED CLOSELY DURING PERI-TRANSPLANT AND EARLY POST-TRANSPLANT PERIODS FOR INFECTIOUS COMPLICATIONS BESIDES ANTIMICROBIAL PROPHYLACTIC THERAPIES APPLIED UNTIL RECOVERY OF HEMATOPOIETIC AND IMMUNE SYSTEMS. EVIDENCE OF STEM CELL ENTRAPMENT IN AN69 MEMBRANES DURING CONTINUOUS RENAL REPLACEMENT THERAPY.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE REPORT, A 10-YEAR-OLD PEDIATRIC PATIENT WITH A TWO-YEAR HISTORY OF BONE MARROW FAILURE AND CHRONIC KIDNEY DISEASE DEVELOPED SEPTIC SHOCK IMMEDIATELY AFTER THE CONDITIONING REGIMEN BEFORE THE SCHEDULED ALLO-HSCT (ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION), SUBSEQUENTLY REQUIRING ADMISSION TO THE PICU. THE PATIENT'S SEPSIS AND ACUTE KIDNEY INJURY WERE MANAGED USING CVVHDF (CONTINUOUS VENO-VENOUS HEMODIAFILTRATION) WITH A BIOCOMPATIBLE, HIGH-PERMEABILITY AN69 MEMBRANE AND BROAD-SPECTRUM ANTIMICROBIAL THERAPY, WHILE THE POSTPONED ALLO-HSCT WAS PERFORMED SUCCESSFULLY. VASCULAR ACCESS WAS OBTAINED USING AN 8 FRENCH TEMPORARY DUAL-LUMEN VENOVENOUS HEMODIALYSIS CATHETER (COVIDIEN INC.) INSERTED VIA THE LEFT INTERNAL JUGULAR VEIN BY THE INTENSIVE CARE TEAM.THE PATIENT DEVELOPED NEUTROPENIC FEVER DURING THE FINAL 2 DAYS (ON THE LAST DAY OF ANTI-THYMOCYTE GLOBULIN THERAPY, DAY -1) OF THE REDUCED-INTENSITY CONDITIONING REGIMEN. ESCHERICHIA COLI, SENSITIVE TO ALL ANTIBIOTICS TESTED, WAS CULTURED FROM BOTH BLOOD AND CATHETER SAMPLES, SUGGESTING GASTROINTESTINAL TRANSLOCATION AS THE SOURCE OF INFECTION. DESPITE MEROPENEM TREATMENT IN THE TRANSPLANTATION UNIT, THE PATIENT'S CONDITION PROGRESSED TO MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS), NECESSITATING TRANSFER TO THE PICU FOR ADVANCED CARE. E. COLI SEPSIS WAS CONSIDERED TO BE OF ENTERIC ORIGIN; THEREFORE, THIS WAS NOT A CATHETER-RELATED EVENT. AT THIS CRITICAL JUNCTURE, THE PEDIATRIC BONE MARROW TRANSPLANT TEAM DECIDED TO ADMINISTER THE PREPARED ALLOGENEIC HSCT GRAFT FROM A FULLY MATCHED SIBLING DONOR TO TREAT THE PATIENT'S PRIMARY DISEASE, APLASTIC ANEMIA, WITHOUT FURTHER DELAY. PATIENTS ALSO RECEIVE SPECIFIC IMM UNOSUPPRESSIVE MEDICATIONS FOR GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS. THE INFUSION WAS PERFORMED VIA A CENTRAL VENOUS CATHETER AT THE 20TH HOUR OF CVVHDF. THUS, PATIENTS ARE FOLLOWED CLOSELY DURING PERI-TRANSPLANT AND EARLY POST-TRANSPLANT PERIODS FOR INFECTIOUS COMPLICATIONS BESIDES ANTIMICROBIAL PROPHYLACTIC THERAPIES APPLIED UNTIL RECOVERY OF HEMATOPOIETIC AND IMMUNE SYSTEMS. EVIDENCE OF STEM CELL ENTRAPMENT IN AN69 MEMBRANES DURING CONTINUOUS RENAL REPLACEMENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867826 DIALYSIS UNKNOWN CATHETER, HEMODIALYSIS, IMPLANTED MSD COVIDIEN LLC DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Unknown Required Intervention| O