B.BRAUN 4555Recalls & reported problems

B. Braun Medical Inc. · Duosol™ Bicarb 35 Dialysate K4/Ca3 2x5000 mL (4555) · Class 2

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 04046963330910), received between Jul 2, 2024 and Jul 2, 2024 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

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.

MalfunctionJul 2, 2024
REGISTERED NURSE (RN) PREPARED TO UTILIZE DIALYSATE BAG FOR CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND NOTED THAT THERE WAS LEAKING COMING FROM A CREASE IN THE PLASTIC OF THE BAG. THIS BAG WAS SET ASIDE FOR RISK MANAGEMENT AND ANOTHER BAG WAS SELECTED. THIS BAG WAS NOT UTILIZED IN PATIENT CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19654808 ↗

Device details

UDI-DI	`04046963330910`
Brand	B.BRAUN
Model	4555
Company	B. Braun Medical Inc.
Product code	KPO · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 6, 2023

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.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.