MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. H/S CUVETTE 1/4X1/4-JAPAN; BLOOD GAS MONITOR

Model Number CV-6914

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, when attaching bpm, the cuvette was not detected when the cdi cuvette 1/4¿ was connected to the cdi unit.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.No patient involvement as this occurred during setup.Product was changed out.Procedure 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 march 28, 2017.(b)(4).The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.Upon evaluation of the returned sample, it was found that the magnet was rusted.The sample was then not able to connect to the cdi500 monitor, and the magnet strength was found to be below specification.The likely cause of the cuvette not being detected during use is that the magnet was rusted and damaged, causing it to not be strong enough to be detected by the monitor when connected to the probe.This event could be 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: H/S CUVETTE 1/4X1/4-JAPAN
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921
• MDR Report Key: 6438760
• MDR Text Key: 71000069
• Report Number: 1124841-2017-00046
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CV-6914
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00699753270138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1