Recall Z-2218-2012 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
System 8000 Base Product Usage: 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 | Aug 16, 2012 (initiated Jun 20, 2012) |
| Status | Terminated |
| Reason | During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc |
| Root cause | Labeling mix-ups |
| Action | Terumo field correction/service records were completed in 2007 and all affected units were corrected in the field in March 2007 by replacing the incorrect label at the customer location. For questions about this report call 734-741-6056. |
| Quantity | 3 |
| Distribution | US Nationwide Distribution - including the state of New York |
| 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 |