CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later

FDA device recall Z-1252-2010 · posted 2010-04-06 · Terminated

Recall details

Recalling firm

Picis Inc.

Reason for recall

Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update status. At this point, the order documentation becomes frozen at the last dose and/or rate and the user is unable to modify, stop or delete it. This error could impact the fluid bala

Action taken

Picis issued letter notification beginning on March 8, 2010 with software correction information. The letter communicates details of the problem, along with recommendations for mitigating the potential to experience this error condition. Use of the product should be discontinued until the update described in the letter is performed. Customers with questions should call the company at 781-557-3000.

Root cause

Software design

Status

Terminated

Product code

NSX

Quantity affected

23

Distribution

NJ Canada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain.

Date initiated

2010-03-08

Date posted

2010-04-06

Date terminated

2013-07-01

Location

Wakefield, MA