Device Recall Alaris Pump Module model 8100 의 리콜

Recall

77279

Class 2

Z-2700-2017

2017-06-12

2017-06-19

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155608

There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the alaris pump module model 8100.

An Urgent Medical Device Recall letter will be sent on 6/12/17 to customers to inform them that BD is issuing this letter to inform you of a potential risk associated with the Alaris Pump module. Firm identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. This scenario is reproducible under the following situations: a) the user does not close the roller clamp on the IV administration set before the pump door is opened as recommended, and b) opening the pump door using an atypical technique with the door latch with the centered sear design. The letter instructs customers If their device has a centered-sear that was manufactured between June 2002 to June 2004, clearly mark and sequester (e.g. Biomed department) the Alaris Pump module that exhibited the issue. Notify CareFusion Customer Advocacy at 888-812-3266 or customerfeedback@carefusion.com to coordinate an onsite remediation or send the devices to the BD Service Depot.