CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System

FDA device recall Z-1250-2016 · posted 2016-03-25 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Specific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on the CDI System 500 monitor. Terumo Cardiovascular Systems (Terumo CVS) received complaints of inaccurate temperature measurements for specific devices distributed since November 5, 2015. These include both new production devices and recently serviced devices. POTENTIAL HAZARD There have been no reported illnesses or injuries as a result of this issue. A user who is not aware that the CDI System 500 is displaying inaccurate temperature values may not manage patient temperature appropriately. Using inaccurate information to manage warming and cooling strategies for a procedure could result in prolonged time on bypass. It could also lead to unnecessarily aggressive temperature management, resulting in excessive hyper or hypothermia, with potential neurologic and organ dysfunction, or increased blood component damage. Inaccurate temperature measurement could also cause inaccurate measurements of other BPM values including potassium (K+), pO2, pCO2, and pH. The greater the temperature inaccuracy, the greater the degree of inaccuracy of these other BPM values due to the dependence of their algorithms on temperature for the calculations. Inaccurate measurement of these values could result in inappropriate patient management strategies being employed to address them with the potential to result in moderate patient injury.

Action taken

Terumo sent an " URGENT MEDICAL DEVICE RECALL" notification dated March 14, 2016, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The Recall Notification has instructions for responding to the formal recall notification. If you have questions, contact Terumo CVS Customer Service: 800.521.2818 Customer Service Hours: Monday Friday 8 a.m. 6 p.m. ET

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DRY

Quantity affected

222

Distribution

Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates.

Date initiated

2016-03-14

Date posted

2016-03-25

Date terminated

2017-03-28

Location

Ann Arbor, MI

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