URGENT Field Safety Notice Hemotherm Models 400CE and 400MR

Transcription

1 27 November 2017 Attention Valued Customer, URGENT Field Safety Notice Hemotherm Models 400CE and 400MR 27 November 2017 Device Modification (Labeling) Details on affected devices: This is to inform you of a Medical Device Modification involving All Hemotherm models (Model 400CE and Model 400MR) manufactured within the last 12 years. We began shipping this product on 27 November See enclosed product label (IFU) for ease in identifying the product. Description of the problem: This Medical Device Correction has been initiated to provide a labeling update to the cleaning & disinfection procedures. The update addresses the disinfection process, cleaning of reusable accessories, as well as clarifying the water type that should be used with the Hemotherm. Use of, or exposure to, the Hemotherm is not likely to cause adverse health consequences. Advise on action to be taken by the user: 1) Immediately examine your inventory and identify product subject to the correction. 2) Discard your current Hemotherm Operation & Technical Manual and Operation Manual. 3) Replace your current Hemotherm Operation & Technical Manual and Operation Manual with the updated manuals found at If you would like CSZ to provide you with a printed copy, please contact CSZ at the number provided below and copies will be provided to you immediately. For your convenience, a Summary of Changes in the cleaning & disinfection procedure is attached. Additionally, all updates have been highlighted in the manuals. 4) Please complete and return the below response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that you have performed and completed the requested actions. Return the form by mail, fax or scan and to FA @genthermcsz.com A

2 Transmission of this Field Safety Notice: This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Contact reference person: Kathy DeSmidt Phone: or Fax: The undersigned confirms this notice has been submitted to the appropriate Regulatory Agencies. We apologize for any inconvenience this may cause you and thank you for your cooperation. If you have any questions, please contact our Field Action Coordinator listed above. Sincerely, Christina M. Miracle Christina M. Miracle Manager of Regulatory Compliance A Page 2 of 4

3 Return Response Form Please complete this form after your facility has performed the instructions provided in the Medical Device Correction notification. Please check ALL appropriate boxes: I have read and understand the instructions provided in the notification. I have checked my inventory and my facility has affected Hemotherm devices. Please list your Hemotherm serial numbers: I have replaced our current Hemotherm Operation & Technical Manual and Operation Manual with the updated manuals. If you have further distributed this product, please check the appropriate box: I have identified and provided a copy of the Medical Device Correction notification with the Return Response Form to my customers that were shipped or may have been shipped this product via ; OR (Specify method of notification and date) I would like CSZ to notify my customers. Attached is a list of customers who received/may have received this product. Signature Date Printed Name Address Facility Name Facility Address, City, State, Zip Code Phone Number Return the form by fax or . FA @genthermcsz.com Fax: A Page 3 of 4

4 Hemotherm 400CE/MR Cleaning & Disinfection Procedure Summary of Changes Prior Manuals Updated Manuals Water Type Distilled or sterile Sterile water or water that has been passed through a filter of less than or equal to 0.22 microns Draining/Refilling Frequency Monthly No Change Cleaning/Disinfecting Frequency Quarterly No Change Cleaning Agent None Prolystica 2X Concentrate Enzymatic Presoak and Cleaner Cleaning Agent Amount (ml) N/A 30.4 Cool Reservoir 22.8 Heat Reservoir Disinfecting Agent Household Bleach Bleach (6% or 8.25%) Disinfecting Agent Amount (ml) 6% NaHCL 8.25% NaHCL 230 Cool Reservoir 320 Cool 230 Cool 170 Heat Reservoir 235 Heat 170 Heat Water Amount (L) 7.6 Cool Reservoir 5.7 Heat Reservoir No Change Cleaning Reservoir Lids None Wipe down with Tuberculocidal wipe Cleaning In Line Filter Remove and clean Wipe down with Tuberculocidal wipe Cleaning Accessories None A table will be included that provides instruction for cleaning reusable accessories internally Cleaning/Disinfection Duration 5 minutes in each mode Minimum 5 minutes in each mode. Additional circulation time is added if the user attaches accessories Cleaning/Disinfection Temperature C Cool Reservoir 20 C Cool Reservoir C Heat Reservoir 42 C Heat Reservoir Water Additive U.S.P Grade Propylene Glycol None Water Additive Amount (ml) 290 Cool Reservoir 210 Heat Reservoir N/A Number of Rinses with Water Three No Change A Page 4 of 4

5 R OPERATION & TECHNICAL MANUAL (MODELS 400CE or 400MR) DUAL RESERVOIR COOLER/HEATER Cincinnati Sub-Zero Products, LLC Mosteller Road Cincinnati, Ohio 45241, U.S.A.