CDI System 100 Monitoring System

• • Terminated Z-2610-2011 FDA Unclassified (pre-2012) ·initiated 28 Apr 2011 ·on shared 510(k) K902654

  Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values displayed by the CDI"101 Hematocrit/Oxygen Saturation Monitoring System: hematocrit (HCT), hemoglobin (Hgb) and Oxygen Saturation.

• 2 recalls, same reason

  • Terminated Z-2683-2011 FDA Unclassified (pre-2012) ·initiated 21 Apr 2011 ·on shared 510(k) K902654
  • Terminated Z-2684-2011 FDA Unclassified (pre-2012) ·initiated 21 Apr 2011 ·on shared 510(k) K902654

  Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. Because the pH value is used to calculate other values, these parameters could also be affected by the presence of Methylene Blue: K

• 2 recalls, same reason

  • Terminated Z-1943-2011 FDA Unclassified (pre-2012) ·initiated 1 Nov 2010
  • Terminated Z-1944-2011 FDA Unclassified (pre-2012) ·initiated 1 Nov 2010

  Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Cdi (Tm) System 100 Monitoring System

510(k) Number

K902654 ↗

FDA Product Code

DTY

Device Class

Class II

Regulation

21 CFR Part 870.4410

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 480cm Infusion Pump, Modification

  Class II

  FDA 510(k) K924869 Active Cleared 17 Jun 1993

• 3M Prevention Fabric Surgical Gown #78XX

  Class II

  FDA 510(k) K930681 Active Cleared 10 Feb 1994

• 3M Precise Brand Internal Surgical Staples

  Class II

  FDA 510(k) K921051 Active Cleared 16 Jul 1992

• 3M Pediatric Laparotomy Sheet #7938/ #7938NS

  Class II

  FDA 510(k) K946024 Active Cleared 8 Feb 1995

• 3M X-Large Sheet #7979/ #7979NS

  Class II

  FDA 510(k) K946025 Active Cleared 2 Feb 1995

• Red Dot 2515 Cardiac Sensor System

  Class I

  FDA 510(k) K924487 Active Cleared 23 Dec 1992

See all devices from 3M Health Care, Ltd. →

• What is the primary clinical application of the CDI System 100 Monitoring System?

  The CDI System 100 is an in-line blood-gas sensor specifically designed to provide real-time monitoring of blood-gas parameters during cardiopulmonary bypass procedures.

• What is the regulatory status of the CDI System 100?

  The device is classified as a Class 2 medical device under regulation number 870.4410 and received FDA 510(k) clearance on November 5, 1990, through the traditional pathway.

• Who is the manufacturer of the CDI System 100 Monitoring System?

  The system is manufactured by 3M Health Care, Ltd., based in Irvine, California, and is categorized under the cardiovascular medical specialty.