T34 Technical Bulletin Lead Screw Pumping Block Remediation Ver 03

Service / Technical Bulletin TITLE: T34™ Lead Screw Pumping Block Remediation SWI NUMBER: TB08092

VERSION 03

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1. Background As a result of a Field Safety Notice (FSN#: MMS-19-1572) relating to the T34™ lead screw, a remediation plan was set-forth to replace all pumping blocks with newly designed lead screws pumping blocks. 2. Purpose 2.1 The purpose of this bulletin is to inform distributors/service centers with details of an upcoming remediation in which the pumping block will be replaced on 2nd edition T34™ pumps. 2.2 This bulletin is not applicable to 3rd edition T34™ pumps. 3. Affected products / Scope 3.1 All 2nd edition T34™ syringe pumps currently installed with the exception of T34™ syringe pumps manufactured prior to 2009. • The pumping block assembly is not designed for use on T34™ syringe pumps manufactured prior to 2009. If you have a device with a manufacturing date older than 2009 in your possession, please contact your local BD representative to discuss alternative remediation options. The manufacture year can be identified on the rear label new (see example below).

4. Description 4.1 A fault in the T34™ pumping mechanism’s lead screw design was discovered. This fault may lead to actuator nut being worn enough to stop or lose traction on the lead screw. 4.2 The “wear/tear” effect can be visually observed as the lead screw is progressively wearing the plastic actuator nut overtime, leaving white plastic debris along the lead screw. This may result in the complete abrasion of the actuator’s nut, leading to potential for under infusion situations without the pump alarm being activated.

Service / Technical Bulletin TITLE: T34™ Lead Screw Pumping Block Remediation SWI NUMBER: TB08092

VERSION 03

4.3 BD has redesigned and developed an improved leadscrew to be assembled in the new pumping blocks, that will replace the current existing pumping block. 4.4 The newly designed pumping blocks will be retrofitted in all T34™ pumps. Old pumping block currently in pumps P/N: 200-000S - ASSY,BLOCK,PUMPING,T34 New pumping block P/N that replaced ASSY34BKS as of November 5th: ASSY000043 - ASSY,BLOCK,PUMPING,T34, 3.1ED - GAI PROJECT3.1ED (below)

4.5 Both pumping blocks (old and new) look similar, but the new stainless-steel lead screw can be distinguished by the silvery shine (see image below). New lead screw - stainless steel

Old lead screw

Please note: the plastic cap/cover may bulge a bit. This may affect the actuator movement when assembled in pump. Make sure to press down on the actuator cap so that it is flush (aligned) or pressed in actuator (refer to images below): (1) Bulging cap/cover

(2) Pressing cap/cover

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Service / Technical Bulletin TITLE: T34™ Lead Screw Pumping Block Remediation SWI NUMBER: TB08092

VERSION 03

(3) Cap/cover is pressed in

Please note: Do not remove the cap as it prevents from particles accumulating on the lead bar contacts.

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