3 L NON STERILE WASTE BAGS IB0507009Recalls & reported problems
Bellco Srl · 3 L NON STERILE WASTE BAGS · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 08051736003768), received between Sep 16, 2022 and Sep 16, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 18, 2026.
Most reported problems
Device problems
- Insufficient Flow or Under Infusion1
- Product Quality Problem1
Patient problems
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2022Product Quality Problem; Insufficient Flow or Under Infusion; Product Quality Problem; Insufficient Flow or Under Infusion
ACCORDING TO THE REPORTER, THE CVVHD (CONTINUOUS VENO-VENOUS HEMODIALYSIS) TREATMENT STARTED AT 1700 ON (B)(6) 2022 RUNNING WELL. ON (B)(6) AT 1115, THE MACHINE HAD AN ALARM 71 INF/DIA PROFILE VARIANCE ALARM THAT WERE NOT ABLE TO CLEAR THE ALARM AND REQUIRED A SCALE CALIBRATION. THIS WAS THE FIRST SCALE CALIBRATION OF THE TREATMENT. QUICKLY AFTER, THEY ALSO RECEIVED AN ALARM 78 INSUFFICIENT DIALYSIS FLOW AND IMMEDIATELY NOTICED A HOLE IN THE MIDDLE OF THE EFFLUENT BAG LEAKING ON THE FLOOR. IT WAS SAID THAT THEY SHOULD HAVE RECEIVED AN ALARM 70 EFFLUENT PROFILE VARIANCE WHEN THERE WAS A LOSS OF 6G FROM THE BAG NOT ALARM 71 INF/DIA PROFILE VARIANCE. DIALYSIS FLOW RATE 3 ML/MIN, TREATMENT TIME 24 HOURS, TOTAL WEIGHT LOSS 250G, BLOOD FLOW 20 ML/MIN. NOTHING UNUSUAL OBSERVED ON THE MACHINE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. PRIMING WAS DONE PRIOR TO USE WITH NORMAL RESULT. NO COMPONENTS WERE REPLACED. THE PATIENT BECAME ACUTELY HYPOTENSIVE 40/20'S THAT REQUIRED IMMEDIATE DISCONNECTION OF THE MACHINE. THE PATIENT'S BASELINE BLOOD PRESSURE PRIOR TO THE EVENT WAS 70-80/30-40. PATIENT WAS A BLOOD PRIME- DID NOT RETURN BLOOD BUT THE PATIENT DID REQUIRE MEDICAL IN
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 15442555 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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