Sonoclot Analyzer, ACT Machine India, Thromboelastography, Cardiac Surgery, Liver Transplant

Diss e mi na ted Int rav ascu l a r Co agu l at i on (D I C) The DIC process can be divided into three sta g es: •   Hypercoagulable (Stage I) •   Secondary fi br i no l yt i c (Stage II) •   Hypocoagulable (Stage III) Hy p e rcoagul a b l e ( S t a ge I ) DIC i s commo nly i n i t ia t e d th ro ugh rel e as e o f t issu e fa c t or (TF) and F V IIa act i vat i on of the ex t r i ns i c path w ay, resu l t in g i n a dep o s i t i on of th r omb i n i n the microci r c u la t io n s y s t em . TF i s norma l l y co nt ai n e d w i th i n t he cell u l a r membra ne a nd encrypted. However, t r aumat i c t i ssue i njury, r e quired major resuscitation, or major surgery, exposes TF to the bloodstream. TF expression can also oc c ur when m o nocytes are act i vated by sepsis, e ndotoxin, the presence of cancero u s ce ll s, or i n pregnan c y when amn i ot i c f l u i d penetrates the maternal blood stream. I n s u mmar y, t h

Date Initiated by Firm January 28, 2011 Date Posting Updated March 21, 2011 Recall Status 1 Terminated 3 on March 12, 2012 Recall Number Z-1738-2011 Recall Event ID 57809 510(K)Number K002177    Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA Product TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies Code Information list 07-022 (TEG 5000), all serial numbers Recalling Firm/ Manufacturer Haemoscope Division of Haemonetics Corp 6231 W Howard St Niles IL 60714-3403 For Additional Information Contact Ms. Susan Finneran 800-438-2834 Manufacturer Reason for Recall Haemonetics has received a report of smoke from the unit with a power supply failure. FDA Determined Cause  2 Other Action Haemoscope sent letters to all of their U.S. account