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

Device Problem Connection Problem (2900)

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

Event Date 12/11/2015

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).Conclusions code: conclusion not yet available - evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular systems that during cardiopulmonary bypass a h/s disconnect message displayed.No known impact or consequence to patient.Product was not changed out.Surgery was completed successfully without delay.

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)(6) 2015.The actual sample was not returned for evaluation.The product lot information was not provided; therefore, a review of the device history records could not be performed, nor could a retention sample be obtained for investigation.A complete investigation could not be conducted and this complaint is not confirmed.This event is associated with the voluntary safety alert distributed by terumo on december 8, 2015, 1124841-12/08/2015-004-c, and it was confirmed in other events that are also associated with this safety alert, that during these other events it is likely that the magnets were defective with weak magnetic strengths.These magnets are manufactured by an outside supplier, arnold magnet technologies.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: 5323958
• MDR Text Key: 34275283
• Report Number: 1124841-2015-00345
• 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: 03/18/2016

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
• 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: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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