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CARPEDIEM IB0595570Recalls & reported problems

Bellco Srl · BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 015 FOR CARPEDIEM · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08032979792282), received between Jan 5, 2022 and Jan 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Leak/Splash1
  • Protective Measures Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 5, 2022Fluid/Blood Leak; Leak/Splash; Protective Measures Problem; Fluid/Blood Leak; Leak/Splash; Protective Measures Problem

    ACCORDING TO THE REPORTER, THE MACHINE WAS SET UP FOR A PATIENT TREATMENT AND DURING THE PRIMING PHASE THE NURSE NOTICED THAT THE FLUID WAS LEAKING FROM THE PRE-FILTER PRESSURE TRANSDUCER AREA. PRIMING WAS STOPPED AND THE PREASSEMBLED DEVICE WAS TAKEN DOWN, AND A SECOND DEVICE FROM THE SAME LOT WAS USED AND HAD THE SAME ISSUE AND SO IT WAS REPLACED WITH ANOTHER PRODUCT. THEN A NEW TREATMENT WAS STARTED WITH THE NEW PREASSEMBLED DEVICE., IT WAS ALSO STATED THAT DURING NORMAL PATIENT THERAPY, USER NOTICED A LARGE BLOOD LEAK (WITHIN THE PREASSEMBLED DEVICE, WITHIN THE DIALYZER AND ALSO IN THE EFFLUENT LINE AND INF/DIA LINE CLOSEST THE DIALYZE) . THE THERAPY WAS STOPPED EARLY, AND THE PATIENT WAS DISCONNECTED FROM THE MACHINE, THE PREASSEMBLED DEVICE WAS ALSO TAKEN DOWN, AND A NEW TREATMENT WAS STARTED WITH A NEW PREASSEMBLED DEVICE TO RESOLVE THE ISSUE AND THE TREATMENT WAS COMPLETED. ALARMS WERE ACTIVATED (FIRST OCCURRENCE DURING PRIMING- ALARM 33 MINIMUM PRE-FILTER PRESSURE WAS DISPLAYED. DURING THERAPY ALARM 28 BLOOD LEAKAGE FROM FILTER WAS DISPLAYED.). NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED, INTERVENTION/TREATMENT WAS NOT REQUIRED AS A RESULT OF

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13172183 ↗

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Sources and updates

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