PV Bulletin

ANSM (France) - Safety information feed: CEC/Ecmo – Echangeur de chaleur – Quantum PureFlow Standard Heat Exchanger High Flow – Spectrum Medical S.r.L sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Informatio

Safety information published by ANSM regarding Quantum PureFlow Standard Heat Exchanger by Spectrum Medical S.r.L.

Primary source: Téléchargez le courrier de la société Spectrum Medical S.r.L (02/09/2026)

Translated From Another Language

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

ANSM released safety information on the Quantum PureFlow Standard Heat Exchanger, specifically addressing concerns about its use in healthcare settings.

Why it matters

The safety of medical devices like the Quantum PureFlow is crucial to prevent risk and ensure patient safety in healthcare environments.

Action needed

Pharmacies within healthcare establishments must review the safety information and adhere to the guidance issued by ANSM regarding the usage of the device.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 2, 2026

Full briefing

Practical implication

Pharmacies within healthcare establishments must review the safety information and adhere to the guidance issued by ANSM regarding the usage of the device.

The French National Agency for the Safety of Medicines and Health Products (ANSM) has published safety information concerning the CEC/Ecmo Quantum PureFlow Standard Heat Exchanger High Flow from Spectrum Medical S.r.L. This information includes important safety details to be noted by healthcare institutions using this device.

What changed: ANSM released safety information on the Quantum PureFlow Standard Heat Exchanger, specifically addressing concerns about its use in healthcare settings.

Why it matters: The safety of medical devices like the Quantum PureFlow is crucial to prevent risk and ensure patient safety in healthcare environments.

Practical implication: Pharmacies within healthcare establishments must review the safety information and adhere to the guidance issued by ANSM regarding the usage of the device.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-02T00:00:00.000Z
  • Discovered by monitor: 2026-09-02T21:40:22.588Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Device Vigilance#Source-ingestion#Regulator-monitor#France#Ansm.sante.fr#Translated From Another Language

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