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

Model Number CV-6913

Device Problem Connection Problem (2900)

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

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned and the lot number of the affected product was not provided; therefore, a complete investigation could not be performed and a root cause could not be determined.This event could be associated with a voluntary safety alert submitted by terumo on (b)(6) 2015.The safety alert number is (b)(4).(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the cuvette measurements were not indicated.This event could be associated with a voluntary safety alert submitted by terumo on (b)(6) 2015.The safety alert number is (b)(4).No known impact or consequence to patient.Product was not changed out.Procedure completed successfully.

• Brand Name: H/S CUVETTE 3/8X3/8-JAPAN
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6497017
• MDR Text Key: 72992270
• Report Number: 1124841-2017-00063
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K915265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-6913
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00699753270121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• 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