第7周：医疗器械全球法规动态
Field Corrective Actions
Date | Title: |
13.02.2025 | Urgent Field Safety Notice for Anti-TPO by Orgentec Diagnostika GmbH Product group In-vitro diagnostics - immunological products |
13.02.2025 | Urgent Field Safety Notice for TENDON SPACER (SWANSON/HUNTER) and various by Wright Medical Technology, Inc. Product group Non-active implants - bone surgery |
13.02.2025 | Urgent Field Safety Notice for MiniMed 640G, 670G, 720G, 740G, 770G, 780G by Medtronic Minimed Product group Injections / Infusions / Transfusions / Dialysis - infusion technology |
13.02.2025 | Urgent Field Safety Notice for Eschweiler combiline/Eschweiler modularPro by Eschweiler GmbH & Co. KG Product group In-vitro diagnostics - haematological, histological and cytological products |
11.02.2025 | Urgent Field Safety Notice for Leica CM1950 by Leica Biosystems Nussloch GmbH Product group In-vitro diagnostics - instruments, apparatuses and systems |
11.02.2025 | Urgent Field Safety Notice for HemosIL Heparin by Instrumentation Laboratory Co. Product group In-vitro diagnostics - equipment / products for clinical chemistry |
11.02.2025 | Urgent Field Safety Notice for Contec CMS8000 by Contec Medical Systems Co., Ltd. Product group Medical electronics / Electromedical devices - electrodiagnostics |
11.02.2025 | Urgent Field Safety Notice for In2Flow Nasal cannula by Hamilton Medical AG Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply |
11.02.2025 | Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH Product group Medical data processing (software) - others |
11.02.2025 | Urgent Field Safety Notice for Philips Azurion, Philips Allura by Philips Medical Systems Nederland B.V. Product group Radiological technology - radiological equipment for vascular diagnostics |
10.02.2025 | Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc Product group Medical electronics / Electromedical devices - electric blood glucose meters |
10.02.2025 | Urgent Field Safety Notice for Origin Data Management, 3.1 by Brainlab AG Product group Medical data processing (software) - data processing facilities for image processing |
10.02.2025 | Urgent Field Safety Notice for Philips Azurion, Philips Allura by Philips Medical Systems Nederland B.V. Product group Radiological technology - radiological equipment for vascular diagnostics |
10.02.2025 | Urgent Field Safety Notice for HAMILTON-C2, HAMILTON-C3 by Hamilton Medical AG Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply |
10.02.2025 | Urgent Field Safety Notice for T2 Rigid Reamer by Stryker Trauma Kiel Product group Medical instruments for use in humans - bone surgery |
MHRA本周发布信息
Guidance
Digital mental health technology: qualification and classification
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
13 February 2025
Guidance document replaced with version 1.1 which has changes to the wording of Example 6 (p17) and Example 14 (p46)
Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal
This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
Product Names: Impella RP with SmartAssist and Impella RP Flex with SmartAssist Unique Device Identifier (UDI)/Model: 00813502011869 and 00813502012811 Lot/Serial Numbers: All devices
What to Do
On December 12, 2024, Abiomed Inc. sent all affected customers an Urgent Medical Device Correction notificationExternal Link Disclaimer recommending the following actions:
Product is NOT being removed from the field and does not need to be returned. Forward this notice to anyone in your facility that needs to be informed. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. Use updated instructions for use, found in the Urgent Medical Device Correction notification, when inserting, manipulating, or removing concomitant devices.
Reason for Updates to Use Instructions
Abiomed Inc. has updated the use instructions for the Impella RP with SmartAssist and Impella RP Flex with SmartAssist due to a risk that the tip of guidewires or other medical devices may come into contact with the Impella pump during insertion, adjustment, or removal. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop. This may trigger alarms and cause a loss of certain heart and blood pressure readings.
There have been no reported injuries. There have been no reports of death.
Device Use
The Impella RP Flex with Smart Assist System Catheter is used for up to 14 days in patients that develop acute right heart failure after left ventricular assist device implantation. The device is placed via the internal jugular vein and supports the right chamber of the heart (ventricle) by pumping blood into the pulmonary artery.
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