Events

Recall of Device Recall CDI Blood Parameter Monitoring System; CDI 500 Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68240
  • Event Risk Class
    Class 2
  • Event Number
    Z-1634-2014
  • Event Initiated Date
    2014-05-09
  • Event Date Posted
    2014-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127202
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Blood Parameter Monitoring System - Product Code DRY
  • Reason
    There is a potential for inaccuracies in blood gas readings/measurements. there is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paco2. if the hemoglobin and hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. bpm shipped without meeting manufacturing accep.
  • Action
    On 5/9/14, TCVS placed a phone call to the one affected customer regarding the recall. The phone call explained the reason for the recall, identification of affected product, potential hazard, and instructions for return of affected product.

Device

Device Recall CDI Blood Parameter Monitoring System; CDI 500 Monitor
  • Model / Serial
    Catalog Number or Part Number 145891 500AVHCT  Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    one customer in IA
  • Product Description
    CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA