Terumo—Trima Accel Automated Blood Collection Systems: Defective Electric Cables May Cause Nonrecoverable Power Failure
May 24, 2017 | Risk Management News
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In a May 1, 2017, Voluntary Medical Device Product Recall letter submitted by an ECRI Institute member hospital, Terumo states that the above blood collection systems may contain defective electrical cables, potentially resulting in a nonrecoverable power failure. If a power failure occurs before the start of a procedure, it may cause a delay in the procedure while the device is repaired or another device is located. If a power failure occurs after the procedure has begun, the procedure cannot be completed and the automated Rinseback cannot be performed. Extracorporeal volume (ECV) varies dependent on the protocol chosen and procedural conditions. Maximum ECV for Trima Accel protocols in which platelet-capable tubing sets are used is 196 mL and for RBC/plasma, it is 182 mL. Instructions to complete a manual Rinseback are outlined in the system's operator's manual. If Rinseback is not completed, the physician should determine the effect on the patient and any intervention needed. Terumo further states that it has received no reports of device failure related to this problem. The manufacturer has not confirmed the...