NA - NA 115959Recalls & reported problems
Gambro Dasco SPA · Accessory Drain Bag (5L); Accessory for hemodialysis · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07332414121594), received between Jan 6, 2026 and Apr 3, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A TEAR WAS OBSERVED IN A PRISMAFLEX 5L EFFLUENT BAG AND THE BAG LEAKED DURING THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778046 ↗MalfunctionJan 6, 2026Break
IT WAS REPORTED THAT THE DRAIN PORT OF A PRISMAFLEX 5L EFFLUENT BAG WAS OBSERVED TO BE BROKEN DURING USE, AND THE BAG WAS "FOUND WET". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980367 ↗
Other SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES devices
- NA 6033765Gambro Dasco SPA · SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES11 reports
- NA 114423Gambro Uf Solutions, Inc · SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES4 reports
- AUTO EFFLUENT SET 115370Gambro Uf Solutions, Inc · SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES3 reports
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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