Addendum to Instructions for Use
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The Chief Executive Officer URGENT PRODUCT DEFECT CORRECTION Caesarea Medical Electronics T34 Syringe Pumps Serial numbers: All serial numbers ARTG No: 131232 TGA Ref. No.: RC-2019-RN-01425-1 Product defect reason: The manufacturer, BD/CME has issued this Urgent Product Defect Correction to inform users of the T34™ Ambulatory Syringe Pump of an update to the Instructions for Use (IFU) and the Technical Service Manual to include revised inspection and cleaning practices for these pumps. Through customer feedback BD/CME has identified that there is a potential for fluid to ingress into the T34™ pump from routine cleaning and disinfection, which could over time, depending on the cleaning practice used, result in damage to the pump components, leading to potential impact on pump performance. As a result of this, BD/CME is revising the “Manufacturer Recommended Cleaning” instructions in the IFU (Appendix 1) and is updating the Technical Service Manual to include instructions for preventive maintenance (Appendix 2) to limit cumulative effects of fluid ingress over time. This notification is to make you aware of these changes and to provide copies of these revised instructions to be used with your pumps. Refer to Appendix 1 and Appendix 2. Please note that there is no requirement for customers to return or discontinue use of the T34™ Ambulatory Syringe Pumps. Action to be taken: 1. Read and distribute this Urgent Product Defect Correction Notice and ensure that all the contents are understood by those within your organisation and/or service organisation who need to be aware. 2. Attach Appendix 1 to the current IFU for your pumps and ensure its contents are made available to users that complete routine cleaning and disinfection practices for the T34™ pump. 3. Attach Appendix 2 to the current Technical Service Manual for your pumps and ensure its contents are made available to those in your organisation that perform the servicing/or your service provider. The guidance provided in the Technical Service Bulletin should be implemented and used at the next scheduled service/routine maintenance for the pumps. 4. Complete the attached acknowledgment form and return via email whether or not you have affected product, as we are required to confirm receipt of this notification from you. 5. If any of the stock could have been transferred from your facility to another, please immediately let that facility know of this notice and also notify REM SYSTEMS. Page 1 of 11
This action has been undertaken after consultation with the Therapeutic Goods Administration If you have any further questions please do not hesitate to contact us on Freecall 1800 737 222. Tony Edmonds
Regulatory Affairs Manager Monday, October 14, 2019
Appendix 1 i Addendum to the Instructions for Use for the T34 TM Ambulatory Syringe Pump (Instructions for Use document reference number: 100-090SM / 100-090SS)
Manufacturer Recommended Cleaning (MRC) Instructions jDQ]dVQScdaUa IUS^U]TUT 7[UQ]Y]Wk (MRC) protocol is to preserve pump performance. To clean the pump, wipe the external pump surface by exclusively using disposable wipes impregnated with isopropyl alcohol (IPA) 70%, to minimize pump exposure to excessive quantities of liquids. Isopropyl alcohol is volatile and leaves no residue upon evaporation, therefore surfaces are left dry quickly after wiping. The intent of the MRC protocol is to remove particles and chemical residue that could accumulate over time on pump surface resulting from normal use and from the rY^h^c[ZXi^dc egdidXda , gZ^bZs developed by users at point of use. It is highly recommended to apply on pump the MRC protocol on a regular basis and after each disinfection sequence as a preventive measure to maintain pump performance. It is also recommended to clean the pump using the MRC protocol between patient use and when the pump is visibly soiled. Note: Preventive maintenance also helps to maintain pump performance over time. This should be performed as recommended in the maintenance section within this DFU. ) ) ) )
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Warning: Turn off the pump. Warning: When fluid ingress is suspected, stop using the pump and request pump verification through maintenance to identify potential need of corrections. Caution: Immersing the pump into liquid could cause damage to components. Do not soak or immerse any part of the pump or the pump charger in water or any other solution. Caution: If other chemical cleaning agents are jhZY [dg rY^h^nfectioc egdidXda , gZ^bZs+ Ensure to follow the Manufacturer recommended cleaning to preserve pump performance, post completion of i]Z rY^h^c[ZXi^on protocol / regimes+ Caution: Do not spray or rinse cleaning solutions directly on pump surfaces or in potential liquid retention areas or open ports such as electrical connections. Caution: Avoid using chemicals that can damage the surfaces of the instrument (e.g. chlorinated solvents). Caution: When using cleaning solutions containing chemicals (such as corrosive agents), do not use concentrated solutions and do not expose surfaces above the recommended dwell time. After application, rinse surfaces with IPA disposable wipes to eliminate chemical residue. Caution: Do not steam, autoclave, EtO sterilize, immerse the instrument or charger in any type of fluids, or allow fluids to enter the instgjbZci XVhZ+ r July 2019
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Appendix 2 i Technical Bulletin / Addendum to the Technical Service Manual for the T34 TM Ambulatory Syringe Pump (Document Reference Number: TB06623 rev 01)
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PLEASE NOTE: THIS ACKNOWLEDGEMENT FORM MUST BE COMPLETED AND EMAILED TO: [email protected]
Product Description:
BD/CME Caesarea Medical Electronics T34™ Ambulatory Syringe Pump.
Serial numbers affected:
All serial numbers.
We acknowledge receipt of this Urgent Product Defect Correction Notification and understand and have actioned the instructions provided.
DATE:
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Name and Address of Responding Organisation
...
...
Name:
...
Position:
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