MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CDI H/S CUVETTE 1/4X1/4; BLOOD GAS MONITOR

Model Number 6914

Device Problem Connection Problem (2900)

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

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the actual 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 more information becomes available.For this reason, terumo referenced (b)(4).

Event Description

The user facility reported to terumo cardiovascular systems, on (b)(6) 2015, that there was an h/s disconnect error during a procedure.At the time, this event was not considered reportable to the fda.A safety alert (1124841-12/08/2015-004-c) was initiated involving this event on (b)(6) 2015; therefore, this event is being reported to the fda in response.No known impact or consequence to patient.Product was not 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 december 23, 2015.Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer), (indication that this is a second follow-up report), (follow-up due to device evaluation), (b)(4).The actual sample was visually inspected upon receipt, during which no anomalies were noted.A review of the device history records could not be performed as the lot information was not provided for the affected sample.The functionality of the cuvette and magnet was evaluated by connecting the unit to the cdi500 monitor.It was found to have difficulties connecting to the monitor.The strength of the sample's magnet was measured and found to be of a lower strength than normal.It is likely that the magnet is defective with weak magnetic strength.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 1/4X1/4
• 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: 5323927
• MDR Text Key: 34267526
• Report Number: 1124841-2015-00333
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6914
• Other Device ID Number: (01)00699753270169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• 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
• Removal/Correction Number: 1124841-12/08/2015-004-C
• Patient Sequence Number: 1