Model note · Blood Gas Analyser

Siemens Healthineers RAPIDPoint 500e Blood Gas System

Name: Siemens Healthineers RAPIDPoint 500e Blood Gas System
Brand: Siemens Healthineers RAPIDPoint

The RAPIDPoint 500e is a cartridge based point of care and laboratory blood gas analyser that measures blood gases, electrolytes, glucose, lactate and CO-oximetry including neonatal bilirubin. It uses a measurement cartridge holding the sensor module and sample probe, a separate wash/waste cartridge and optional automatic QC. The 500e is an updated RAPIDPoint 500: Windows 10 IoT replaced Windows 7 Embedded, main board parts were changed for obsolescence, 2D bar code scanning was added and QC controls were tightened.

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The model

Maker, model and type.

Maker: Siemens Healthcare Diagnostics Inc.
Model: RAPIDPoint 500e Blood Gas System
Device type: Blood Gas Analyser
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Parameters	pH, pCO2, pO2, Na, K, Ca, Cl, glucose, lactate, tHb, sO2, O2Hb, HHb, COHb, MetHb, neonatal total bilirubin	Source
Sample volume	100 uL	Source
Time to results	About 60 seconds	Source
Measurement cartridge	28 days on board or maximum test count; about 24 minutes to initialise; includes new sensor module and sample probe	Source
Quality control	Automatic or ampoule QC, three levels of independent QC solutions, customisable schedule	Source
Operating system and connectivity	Windows 10 IoT; LIS, wireless, Ethernet and serial ports; POCcelerator data management	Source
Lactate method and range	Amperometric lactate oxidase sensor; reportable 0.18 to 30 mmol/L; 2 point calibration from on board reagent	Source
FDA basis	K192240 Special 510(k) modifying the RAPIDPoint 500 (K122539); 21 CFR 862.1120, product code CHL, Class II	Source

Recalls

Known FDA recalls.

Z-2230-20252025-06-26
Wash/waste cartridge lot WW/08925 manufacturing error causing positive and negative bias across several analytes.
FDA record
Z-2214-20242024-05-17
Software v5.3 labelled capillary samples as arterial at the LIS.
FDA record
Z-0606-20242023-10-26
Lactate measurement cartridges could cause negative sodium bias and Question Result flags on electrolytes (also Z-0607 to Z-0609-2024).
FDA record
Z-0422-20242023-09-26
Drug interference from perhexiline maleate or atomoxetine causing falsely high sodium.
FDA record

Safety

Safety warnings from the record.

Perhexiline maleate or atomoxetine can falsely raise sodium on RAPIDPoint 500 and 500e, risking missed hyponatraemia or wrong treatment. Source
Certain lactate cartridges could bias sodium low, which near severe thresholds may lead to harmful sodium correction. Source
In capillary mode, software v5.3 sent results to the LIS labelled as arterial, so they could be judged against arterial ranges. Source
Check the right patient ID is scanned before confirming the sample, as positive identification is a core training point. Source

Sources

Where this note comes from.

Not covered: A copy of the RAPIDPoint 500e Operator's Guide is hosted by a Singapore hospital group but sat behind a bot check and could not be opened, so its error code tables, maintenance schedule, dimensions and power data are not included; only messages named in FDA records are listed. Cleaning and sample handling checks come from one hospital's training sheet. There are 18 recall records for the RAPIDPoint 500 family; older 500 only items (patient ID and data stream issues, 2012 to 2018) are left out. MAUDE counts mix the 500 and 500e and are trends only.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

Blood Gas Analyser