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Important customer notice Medical Device Alert

Medical Device Alert for T34 Ambulatory Syringe Pump Batteries

Ref:2019/647

ICN number:647

  • Date:15/03/2019
  • Product area:Cardio-vascular |

Ref:MDA/2019/013

Alert:

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has issued Medical Device Alert (MDA), in support of Caesarea Medical Electronics (CME) recent production of its combined Field Safety Notices regarding the fitting of batteries in the T34 syringe pump.
  • The initial Field Safety Notice was issued due to the tolerance in size of the T34 syringe pump which is allowed within IEC standards. This notice informed customers that movement of the battery within its housing could lead to loss of connection and in some circumstances may result in the pump shutting down.
  • The MDA Alert informs customers that to improve battery connective, CME are now rolling out a corrective action to fit sponge pads within the battery compartment of the syringe pump.

Products Affected:

  • NHS Supply Chain offer two batteries for use with this pump :
    WPA148 – Duracell Battery alkaline 6LP3146 9V
    WPA147 – Enix Battery alkaline 6LR61 9V.
  • For further information on the affected products, please refer to the MDA below.

Next Steps:

  • Read and follow the full instructions in the MDA below and share this document with all users of the affected products.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

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647 Medical Device Alert

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Should you require further information about this contract, including pricing and how to order the products, please contact your NHS Supply Chain account manager using the link below.

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