The Recall Desk
HighFDA (Devices)·Z-1731-2013·Announced 2013-07-24

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

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

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 during critical surgical procedures (cardiopulmonary bypass) where software inaccuracies could lead to incorrect monitoring data. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the CDI Blood Parameter Monitoring System 500, which includes arterial 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. A software update has been developed to address this issue, and a premarket notification (K130425) has been submitted 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. The recall covers 3,972 units manufactured since April 26, 2012. Users should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the software update.

The recalled product

Product
CDI Blood Parameter Monitoring System 500 with Arterial 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, hematocrit, he
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Monitoring System
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: 500AHCT* and serial numbers: 1023
  • 1025-1027
  • 1029-1031
  • 1034
  • 1035
  • 1037
  • 1040
  • 1045
  • 1048
  • 1054-1058
  • 1060-1062
  • 1064
  • 1065
  • 1072-1074
  • 1076-1095
  • 1098-1100
  • 1106-1110
  • 1114
  • 1116-1129
  • 1131

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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