B BRAUN. Cyto-Set Field Safety Corrective Action TO WHOM IT MAY CONCERN. Effected products see Annex 2 and Annex 3. Dear Sirs,
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1 B. Braun Melsungen AG Division Hospital Care TO WHOM IT MAY CONCERN Your reference Our reference Tel. +49/56 61/71- Fax +49/56 61/71- Date January 14, 2014 Cyto-Set Field Safety Corrective Action Effected products see Annex 2 and Annex 3 Dear Sirs, In the course of internal quality checks we have found that these IV-sets may leak in some cases after disconnection at the Y-shaped Safsite valve, due to an incomplete closing of the valve. (see picture) Kommentar [k1]: Bild Chairman of Supervisory Board: Executive Board: Corporate Office: Melsungen Address: Prof. Dr. h.c. Ludwig Georg Braun Prof. Dr. Heinz-Walter Große Prof. Dr. Hanns-Peter Knaebel Register Court: Local Court Fritzlar B. Braun Melsungen AG (Chairman) Dr. Meinrad Lugan HRB Carl-Braun-Straße 1 Dr. Annette Beller Caroll H. Neubauer, LL.M Melsungen Otto Philipp Braun Markus Strotmann WEEE-Reg.-No. DE Germany (Deputy member)
2 Page 2 to the letter of January 14, 2014 to The silicone disc is not returning into closed position after disconnection of male Luer cone counterparts. Valves, unused or fully connected do not show this defect. In order to ensure product availability and safe use of these products, strictly adhere to the following advice: Cyto-Set (for product list see Annex 2) 1. Strictly perform recapping of the Safsite valve after use as already instructed in IfU. 2. Use always straight Safsite valve to be installed on top of the distal Y-shaped Safsite valve downstream from the pump segment. These straight Safsite valves will be provided free of charge by B. Braun and are not affected by the leakage issue. 3. Strictly follow the recommendations given in the IfU and keep system closed for disposal. Do not disassemble any side infusion devices from Safsite ports above the drip chamber in the main line. Cyto-Set Mix (for product list see Annex 3) 1. Strictly perform recapping of the Safsite valve after use as already instructed in IfU. 2. Use always straight Safsite valves to be installed on top of the affected Y-shaped Safsite valves. These straight Safsite valves will be provided free of charge by B. Braun and are not affected by the leakage issue. Kommentar [k2]: Bild Our records show that your hospital has received Cyto-Set devices from the specific batches listed in the Annexes 2 and 3.
3 Page 3 to the letter of January 14, 2014 to Please forward this information to the users within your hospital immediately. Please accept our apologies for any inconveniences. We kindly ask you to confirm the receipt of this information. Should you have any questions, please call your local B. Braun contact person under Tel xxx-xxxx. Yours sincerely,
4 Page 4 to the letter of January 14, 2014 to No Annex 1 in this letter Annex 2: Article Article text SP PROSET CYTO-SET TYP SPACE M. 3X SAFSITE 3M183400B1 3M023400B1 3M023400B1 3L183400B1 3L183400B1 3K K K SP CYTO-SET INF.SPACE W.3 SAFSITE/BCV/OPAQ. 3L L K SP CYTO-SET INFUSOMAT SPACE M. 3 SAFSITE 3M103400H2 3M093400H2 3L273400H2 3L193400H2 3L L K K K SP CYTO-SET INF.SPACE W.3 SAFSITE/UV-PROT. 3L253400H2 3K SP SP CYTO-SET INFUSOMAT SPACE M.3 SAFSITE/BCV 3M123400H2 3L223400H2 3K PROSET CYTO-SET TYP SPACE MIT 2X SAFSITE 3M103400B1 3M113400B1
5 Page 5 to the letter of January 14, 2014 to Article Article text 3L223400B1 3K K SP PROSET CYTO-SET SPACE LINE 3X SAFSITE 3K SP CYTO-SET INFUSOMAT SPACE M. 5 SAFSITE 3M163400H2 3M133400H2 3M063400H2 3L183400H2 3L293400H2 3L283400H2 3L213400H2 3L183400H2 3L K SP CYTO-SET INFUSOMAT SPACE, UV-PROT. 3M113400H2 3L283400H2 3L203400H2 3L I SP CYTO-SET INFUSOMAT SPACE MIT RSV 3M093400H2 3M073400H2 3L263400H2 3L193400H2 3L203400H2 3L L K K K K I SP PROSET CYTO-SET TYP SPACE MIT 4X SAFSITE 3M103400B1 3L183400B1 3K K
6 Page 6 to the letter of January 14, 2014 to Article Article text SP CYTO-SET INFUSOMAT SPACE 0,2 MY FILTER 3M163400B1 3L SP PROSET INFUSOMAT SPACE LINE 2X SAFSITE 3M063400B1 3K SP CYTO-SET INFUSOMAT SPACE 0,2 MY FILTER 3M163400B1 3L SP PROSET CYTO-SET SPACE LINE 1X SAFSITE 3L203400B1 3L253400B1 3L193400B SP CYTO-SET INFUSOMAT SPACE M. 5 SAFSITE 3M163400H2 3M133400H2 3M063400H2 3L183400H2 3L293400H2 3L283400H2 3L213400H2 3L L183400H2 3K SP CYTO-SET INFUSOMAT SPACE MIT RSV 3M093400H2 3M073400H2 3L263400H2 3L193400H2 3L203400H2 3L L K K K K I
7 Page 7 to the letter of January 14, 2014 to Article Article text SP PROSET CYTO-SET TYP SPACE M. 5X SAFSITE 3M033400B1 3L L K K K SP CYTO-SET INFUSOMAT SPACE W. 5 NF VENTILE 3K SP CYTO-SET INFUSOMAT SPACE, UV-PROT. 3M113400H2 3L283400H2 3L203400H2 3L I SP INFUSOMAT SPACE LTG. M. NUTRIFIX 1000ML 3M113400B1 3M023400B1 3L183400B1 3L K K K SP CYTO-SET INFUSOMAT SPACE M. 3 SAFSITE 3M103400H2 3M093400H2 3L273400H2 3L193400H2 3L L K K K SP PROSET CYTO-SET TYP SPACE M. 3X SAFSITE 3M183400B1 3M023400B1 3L183400B1 3K K SP CYTO-SET INFUSOMAT SPACE M.3 SAFSITE/BCV 3M123400H2
8 Page 8 to the letter of January 14, 2014 to Article SP SP SP Article text 3L223400H2 3K CYTO-SET INF.SPACE W.3 SAFSITE/BCV/OPAQ. 3L L K CYTO-SET INF.SPACE W.3 SAFSITE/BCV/OPAQ. 3L253400H2 3K CYTO-SET INFUSOMAT SPACE W. 3 NF VENTILE 3M053400B1
9 Page 9 to the letter of January 14, 2014 to Annex 3 Article Article text PROSET CYTO-SET MIX M. RV (1X=10 STCK) 3M093400B1 3L273400B1 3K K K PROSET CYTO-SET MIX 3L273400B1 3L PROSET CYTO-SET MIX M. RV UND 0,2µM F. 3M063400B1 3L K K PROSET CYTO-SET MIX M. 0,2µm FILTER A2901N CYTO-SET MIX 3M163400H2 3M193400H2 3M123400H2 3M103400H2 3M093400H2 3L253400H2 3L L193400H2 3L K A29023N CYTO-SET MIX MIT BCV UND 0,2 MY FILTER 3M133400B1 3M043400B1 3K K K A2902N CYTO-SET MIX MIT RSV 3M163400H2 3M033400H2 3M073400H2 3M023400H2 3L283400H2 3L253400H2 3K K
10 Page 10 to the letter of January 14, 2014 to Article Article text 3K K K K K A2905N CYTO-SET MIX WITH BCV - UV PROT. 3M173400B1 3M133400B1 3L223400B1 3K
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