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

Model Number 6922

Device Problem Connection Problem (2900)

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

Event Date 12/14/2015

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

Event Description

The user facility reported to a terumo affiliate that, at an unknown time, there was a cdi cuvette disconnect error.This event is associated with a voluntary safety alert issued by terumo: 1124841-12/08/2015-004-c.No known impact or consequence to patient.Unknown if the product was changed out.Unknown if the surgery was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on december 23, 2015.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

(b)(4).The actual sample was returned for evaluation.The sample was visually inspected, during which no anomalies were noted.A review of the device history records revealed no manufacturing anomalies.The functionality of the cuvette and magnet was evaluated by connecting the unit to the cdi500 monitor.The unit was found to have no difficulties connecting to the monitor and its magnet was measured and found to be within specification.The complaint was not confirmed.This event is associated with the voluntary safety alert distributed by terumo on december 8, 2015, 1124841-12/08/2015-004-c.In other confirmed events associated with the safety alert, it was likely that the magnets were defective with weak magnetic strengths.These magnets are manufactured by an outside supplier, (b)(4).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 road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5324833
• MDR Text Key: 34302934
• Report Number: 1124841-2015-00349
• 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,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2016

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: 06/30/2018
• Device Model Number: 6922
• Device Lot Number: TH06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2016; 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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