The Recall Desk
HighFDA (Devices)·Z-1734-2013·Announced 2013-07-24

Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Inaccuracies

Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because software inaccuracies may affect monitoring during cardiopulmonary bypass.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in critical surgical procedures where software inaccuracies could lead to incorrect monitoring data, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 3,972 units of the CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. The recall affects units with catalog number 500V* and serial numbers 1564-1566, which were distributed worldwide, including the United States, Canada, Australia, and various countries in Asia and the Middle East.

The recall was initiated after Terumo discovered through its own testing that the system's software contains inaccuracies associated with a software algorithm. The device is intended for use during cardiopulmonary bypass procedures to continuously monitor arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature. A software update has been developed to address this issue, and a premarket notification (K130425) has been submitted to the FDA.

Terumo will implement the software update once clearance is received for the premarket notification from the US FDA. The source text does not specify specific actions for consumers or healthcare providers beyond the implementation of the update.

The recalled product

Product
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desire
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Monitoring Systems
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalog number: 500V* and serial numbers: 1564-1566

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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