Device Recall Sarns 8000 Roller pump 의 리콜

Recall

57241

Class 2

Z-0563-2011

2010-11-02

2010-12-08

Terminated

United States

2011-10-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95648

The system 8000 roller pumps may fail resulting in a persistent pump stop.

The firm sent "URGENT MEDICAL DEVICE CORRECTION" dated 11/02/2010 to customers. The letter describes the product, problem and corrective actions taken and/or needed to be taken by the customers. The letter states the system responds to a failed inductor by displaying an overspeed message and stopping the roller pump without an audible alert. The pump cannot be restarted. The customers/users are instructed to stop the pump, replace the pump with a backup or if necessary use the handcrank. The letter states that Terumo will replace the roller pump at the next preventative maintenance visit - or sooner- if the customer has a service contract. If the customer does not have a service contract, Terumo will contact the customer within 2 weeks to set up an appointment for the service. Terumo CVS expects all affected inductors to be replaced to be replaced within three months. Call Terumo CVS Customer Service upon completion of the case at 800-521-2818. The customer was also instructed to complete and return the enclosed CUSTOMER RESPONSE FORM Please note that we are not recommending that you stop using the roller pumps for your Sarns system 8000. For any questions, call toll free 800-262-3304 or phone 734-663-4145.