Recall Z-0126-2013 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
| Date | Oct 24, 2012 (initiated Sep 25, 2012) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction |
| Root cause | Labeling design |
| Action | TERUMO sent an URGENT MEDICAL DEVICE letter dated September 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed review the Medical Device Recall notice, assure that all users are aware of the notice and place the addendum in the Operator's Manual before page 1.13. Customers were also instructed to confirm receipt of the Urgent Medical Device letter by faxing, the attached Customer Response Form to 1-800-292-6551. For questions customers were instructed to call 1-800-521-2818. |
| Quantity | 274 |
| Distribution | Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, CALLO PER |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915183 | SARNS 8000 MODULAR PERFUSION SYSTEM 3M Health Care, Sarns, Jul 8, 1992 |