The Recall Desk
ModerateFDA (Devices)·Z-1730-2013·Announced 2013-07-24

Terumo Recalls CDI 500 Blood Parameter Monitoring System for Software Error

Terumo is recalling the CDI 500 Blood Parameter Monitoring System due to software algorithm inaccuracies. A software update is being developed to correct the issue.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths. The hazard is a software algorithm inaccuracy, which fits the criteria for a moderate severity recall involving potential adverse health consequences that are not severe or life-threatening.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the CDI Blood Parameter Monitoring System 500, which includes Arterial and Venous blood parameter modules and a Hematocrit/Saturation probe. 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.

The recall was initiated after Terumo discovered through its own testing that the system's software contains inaccuracies associated with a software algorithm. The company has developed a software update to address this issue and has submitted a premarket notification (K130425) to the FDA. Once clearance is received, Terumo will implement the update.

The affected units were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and various international locations such as Canada, Australia, Japan, and others. The recall covers 3,972 units manufactured since April 26, 2012. Users should check their device serial numbers against the provided list and contact Terumo for instructions on the software update.

The recalled product

Product
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hema
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Monitoring Equipment
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 (20)

  • Catalog number: 500AVHCT* and serial numbers: 0012
  • 1001-1022
  • 1024
  • 1028
  • 1032
  • 1033
  • 1036
  • 1038
  • 1039
  • 1041-1044
  • 1046
  • 1047
  • 1049-1053
  • 1059
  • 1063
  • 1066-1071
  • 1075
  • 1096
  • 1097
  • 1101-1105

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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