Device Recall Alaris Syringe Pump, Model No. 8110 의 리콜

Recall

71655

Class 1

Z-2362-2015

2015-07-21

2015-08-14

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138585

Channel error code is displayed on the pc unit with an audio and visual alarm, and on the syringe module. after the error is cleared on the pcu, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.

An Urgent Medical Device Recall Notification letter was sent on 7/20/15 to customers who purchased the Alaris Syringe Module (Model 8110) to inform them that CareFusion has identified an issue with the Alaris Syringe module manufactured between March 2014 through September 2014. The letter informs customers of the problems identified and the actions to be taken. CareFusion will replace the syringe drive train assembly on the affected units and adjust, if required. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to contact CareFusion Support Center (888-562-6018, 7am-4pm PT, M-F, supportcenter@carefusion.com) for recall related questions. Customers are instructed to contact Customer Advocacy (888-812-3266, 24hrs/day, 7days/wk, customerfeedback@carefusion.com) for adverse event reports. Customer are instructed to contact Technical Support (888-812-3229, 6am-5pm PT, M-F, dl-us-inf-techsupport@carefusion.com) for technical questions. Customers are instructed to complete and return the enclosed customer response card to expedite the corrective action process. A urgent recall letter for the expansion of the affected units was sent on 10/15/15 to inform customers of the expanded recall. The letter informs customers that the firm has identified an issue with the Alaris Syringe module model 8110 after receiving reports of customers experiencing an channel error on the Alaris Syringe module Model 8110. The letter informs customers that the recall is an expansion of affected units outlined in the CareFusion recall previously issued on 7/20/15. The letter provides the customers with the affected units, issue, potential risk, and actions to be taken. The corrective action for the expanded serial numbers will not change. The affected Alaris Syringe modules will be remediated with a hardware inspection and an adjustment, if required. CareFusion will contact all affected c