Dialysate Sack (SAK) with Concentrate SAK-304Recalls & reported problems

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 M535SAK3040), received between Aug 16, 2019 and Aug 16, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Patient-Device Incompatibility1

Patient problems

Fatigue1
Pneumonia1
Seizures1
Unspecified Infection1
Weakness1

Recent adverse event reports

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

InjuryAug 16, 2019Patient-Device Incompatibility
A REPORT WAS RECEIVED ON (B)(6) 2019 FROM A NURSE STATING THE (B)(6) FEMALE WITH UNSPECIFIED COMORBIDITIES, EXPERIENCED FATIGUE, SILENT SEIZURES, FELT JITTERY, CLAMMY AND WEAK FOLLOWING HEMODIALYSIS TREATMENTS WITH THE PRODUCT ON MULTIPLE UNSPECIFIED DAYS. NXSTAGE THERAPY WAS DISCONTINUED ON (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED ON 07 AUG 2019 FROM THE NURSE REVEALED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2019 WITH OUT OF RANGE LACTATE LEVELS (NOS), PNEUMONIA AND A CATHETER INFECTION. THE PATIENT RECOVERED WITHOUT SEQUELAE AND REMAINED HOSPITALIZED FOR AN UNRELATED HIP REPLACEMENT, DATE OF DISCHARGE NOT AVAILABLE.
Patient problems: Fatigue; Pneumonia; Seizures; Unspecified Infection; Weakness
MAUDE report 8902549 ↗

Device details

UDI-DI	`M535SAK3040`
Brand	Dialysate Sack (SAK) with Concentrate
Model	SAK-304
Company	Nxstage Medical, Inc.
Product code	FKR · Subsystem, Proportioning
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Haemodialysis concentrate

A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

Other Subsystem, Proportioning devices

Dialysate Sack (SAK) with Concentrate SAK-403
Nxstage Medical, Inc. · Subsystem, Proportioning
2 reports

All Subsystem, Proportioning devices →

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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