CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation pro

FDA device recall Z-1730-2013 · posted 2013-07-13 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

Action taken

On 2/27/13, all consignees will receive a recall notification letter via Federal Express. Terumo CVS will correct all affected CDl Monitors. Correction to the devices will be completed concurrently with BPM replacements related to Z-2185/2189-11 RES 57194. Terumo continues to manufacture and ship devices affected by this recall. The long term corrective actions are associated with Recall# Z-2185/2189-11 RES 57194. As committed previously, we will re-notify all customers once we are ready to implement the fix for the BPM in the field. All units produced prior to the change in manufacturing will be included in the scope of this correction. Terumo continues to manufacturer units affected by this correction. All units returned for this correction will be tagged with a service traveler to indicate reason for correction and units will be properly segregated to prevent unintended re-shipment.

Root cause

Software design

Status

Terminated

Product code

DRY

Quantity affected

3972 units since 4/26/12

Distribution

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, N

Date initiated

2013-02-27

Date posted

2013-07-13

Date terminated

2016-02-17

Location

Ann Arbor, MI

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