PrismaSATE 107501Recalls & reported problems
Baxter International Inc. · The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances. · Class 2
All models of PrismaSATE (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 07332414074012), received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
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 16, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A "BROWN/RUST COLORED MARK ON THE INSIDE OF THE TUBE THAT THE BAG WAS SPIKED THROUGH" WAS OBSERVED ON A PRISMASATE BAG PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24100286 ↗
Other DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) devices
- NaturaLyte 08-3251-9Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls78 reports
- NaturaLyte 08-2251-0Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)3 recalls1 death20 reports
- NaturaLyte 08-2301-3Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls35 reports
- Dry Acid Dissolution Unit 160147Fresenius Usa, Inc. · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)129 reports
- GranuFlo 0FD2251-3BFresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls1 death20 reports
- GranuFlo 0FD3251-3BFresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls1 death1 report
- Acidified Concentrate Distribution and Storage (ACDS) System MD704262Isopure, Corp. · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)2 recalls0 reports
- Bicarby RFP-400-GFresenius Medical Care Renal Therapies Group, LLC · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)2 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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