Medical Devices Safety Bulletin (MDSB/2020/02)
Regular safety information for healthcare professionals
This is a pilot for a regular bulletin from MHRA to inform health and care professionals in the UK of new or ongoing safety issues with medical devices. We are no longer issuing medical device alerts (MDA).
To help ensure the safety of patients, we recommend you:
- act on any aspects in this bulletin that will affect your practice or the care you provide
- share the safety messages with colleagues who you think need to know this information
- provide feedback on the bulletin via this so we can ensure it is as clear and effective as possible
The MHRA also issues safety communications for medicines, including Drug Safety Updates. Sign up to receive MHRA email alerts here.
You said鈥�. we did
In feedback, you asked for information on specific devices.
In this edition, we bring you the latest news on battery replacements for the CME / Becton Dickinson (BD) T34 pumps.
The advice in this safety bulletin supersedes the Field Safety Notice issued by the manufacturer in September 2020, which included some restrictions regarding T34 use.
Send us your feedback
Take this to tell us your thoughts on this new safety communication from MHRA
Medical devices safety information
T34 infusion pumps
Actions
- put into use any pumps that were quarantined
- you can use the Duracell Plus battery
- England NHS Supply Chain NPC code WPA244
- Scotland NDC code 253029
- read BD鈥檚
- continue to
Background
The T34 is an ambulatory syringe pump primarily used for palliative care in the UK.
MHRA was made aware of an increased number of reports of battery complaints. As a result, MHRA worked with CME/BD to recommend the Duracell Plus battery as suitable for use within these pumps.
The new battery has successfully undergone extensive testing by both BD and a selection of customers.
MHRA has agreed to lift T34 restrictions and to allow CME/BD to re-start selling the pumps. CME/BD will contact customers regarding this.
MHRA continues to collaborate with external stakeholders and we have recently published a .
Our stakeholders:
Other current T34 safety information:
Updated instructions for use and BodyComm V3.0 software (FSN which supersedes MDA/2019/038)
Lead screw All T34 and T34L (T60) syringe pumps 鈥� risk of under-infusion and no alarm (MDA/2020/007)
Fluid ingress All T34 syringe pumps: Updated cleaning advice and maintenance requirements (MDA/2019/030)
Foam pad for battery All T34 ambulatory syringe pumps battery connection issues (MDA/2019/013)
Sunlight causing bolus T34 and T60: Protect pumps from sunlight and recall of extension sets (MDA/2016/002).
Field Safety Notices
A field safety notice (FSN) is an important communication about the safety of a medical device that a manufacturer, or their representative, sends to customers. For more information, see our flyer
MHRA publishes these for information only. If you have affected devices, the manufacturer or distributor should send the FSN directly to your organisation.
If you are a Medical Devices Safety Officer (MDSO) you can ask manufacturers to add you to their FSN distribution lists.
Targeted letters
A targeted letter (TL) is a safety communication about a medical device, which we send only to the healthcare organisations that have the device.
We will also send TLs to professional bodies and other organisations to send it on to the relevant target audience.
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Reporting safety issues
The Yellow Card scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users.
You should report to via a suspected problem or incident involving:
- side effect to a medicine, vaccine, herbal or homeopathic remedy
- a medical device including diagnostic tests, software and apps
- defective medicine (not of an acceptable quality)
- falsified or fake medicine or medical device
- side effect or safety concern with an e-cigarette
Alternatively, you can download the Yellow Card app (from iTunes for iOS devices or PlayStore for Android devices).
You can also report side effects for medicines through some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank) for healthcare professionals.
There are different ways for healthcare professionals to report a problem with a medical device if you鈥檙e in or .
You can use our new to report any suspected side effects from medicines, future vaccines or medical devices relating to COVID-19 treatment.
Download the bulletin