MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CDI H/S CUVETTE 3/8X3/8; BLOOD GAS MONITOR

Model Number 6923

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.For this reason, terumo referenced evaluation conclusion code.(b)(4).Conclusions code: conclusion not yet available - evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular systems that, at an unknown time, they experienced cdi h/s cuvette errors.This event is associated with a voluntary terumo safety alert: (b)(4); therefore, it is reportable.No known impact or consequence to patient.Unknown is product was changed out.Surgery was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on (b)(4) 2015.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 unit was found have difficulties connecting to the cdi500 monitors.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, arnold magnet technologies.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.

Event Description

Additional information was provided to terumo by the user facility regarding this event.The product was not changed out during the procedure.

• Brand Name: CDI H/S CUVETTE 3/8X3/8
• 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 road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5323957
• MDR Text Key: 34269342
• Report Number: 1124841-2015-00344
• 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: Health Professional
• 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: 05/31/2018
• Device Model Number: 6923
• Device Lot Number: TF18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 05/18/2015
• 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