MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CDI H/S CUVETTE; BLOOD GAS MONITOR

Model Number 6924

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, there was an h/s disconnect error.This event is related to terumo voluntary safety alert: (b)(4).No patient involvement as this occurred during setup.Product was not changed out.Surgery was completed successfully without delay.

Manufacturer Narrative

The sample was not returned for evaluation.A retention sample from the same product code/lot number combination was obtained for investigation.A review of the device history record revealed no manufacturing anomalies.The retention sample was microscopically inspected, and the magnet of the cuvette did not reveal any potential defect that would inhibit part functionality.The retention sample was found to have difficulties connecting to the cdi 500 monitors.The strength of the magnet in the retention unit was measured and was found to be lower than normal.The root cause of this failure is defective magnets that have a low magnetic strength; therefore, this event has been confirmed.These magnets are manufactured by an outside supplier, (b)(4).This event is associated with a voluntary safety alert submitted by terumo on december 8, 2015.The safety alert number is 1124841-12/08/2015-004-c.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CDI H/S CUVETTE
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball rd; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5323962
• MDR Text Key: 34935958
• Report Number: 1124841-2015-00346
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 6924
• Device Lot Number: TF18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1124841-12/08/2015-004-C
• Patient Sequence Number: 1