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CARPEDIEM IB0595580Recalls & reported problems

Bellco Srl · BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 025 FOR CARPEDIEM · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08032979792299), received between Mar 18, 2021 and Mar 18, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Coagulation in Device or Device Ingredient1
  • Product Quality Problem1

Patient problems

  • Anemia1
  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 18, 2021Coagulation in Device or Device Ingredient; Product Quality Problem; Coagulation in Device or Device Ingredient; Product Quality Problem

    ACCORDING TO THE REPORTER, THE PATIENT WHO HAD ANEMIA REQUIRED PACKED RED BLOOD CELLS (PRBC) TRANSFUSION INTERMITTENTLY AT BASELINE WHICH WAS RELATED TO COMPLICATIONS FROM HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH) AND BONE MARROW TRANSPLANTATION (BMT). DURING THE TREATMENT, THE PATIENT HAD WORSENING ANEMIA AND THAT THERE WAS CLOTTING OF THE TWO FILTERS (SINGLE ALL-INCLUSIVE TUBING/FILTER) IN UNDER 1 HOUR, WHICH PREVENTED BLOOD RETURN AND RESULTED IN 80 ML OF BLOOD LOSS. HEMOGLOBIN TEST WAS PERFORMED AND HAD A RESULT OF 6.5. IT WAS MENTIONED THAT IT DID NOT APPEAR THAT THERE WAS A POSSIBILITY OF A PATIENT REACTION CAUSING COAGULATION ISSUES. THERE WERE NO OTHER DIAGNOSTIC PROCEDURES PERFORMED. IT DID NOT RESULT TO THE PATIENT BEING HOSPITALIZED AND THE PATIENT WAS NOT TREATED WITH AN ADDITIONAL CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION. IT DID NOT HAVE MECHANICAL VENTILATION ADDED OR SETTINGS ADJUSTED, NO TREATMENT WITH ECMO INITIATED OR ADJUSTED, AND NO TREATMENT WITH MEDICATION (ADJUSTED, ADDED, OR DOSE REDUCED). THE MACHINE WAS OPERATING AS EXPECTED. THE ADVERSE EVENT WAS TREATED WITH BLOOD PRODUCTS ADMINISTRATION (BLOOD TRANSFUSION) AND THE TUBING SET WAS REPLACED TO RE

    Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

    MAUDE report 11516620 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.