MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. 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 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the actual device; 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.(b)(4).

Event Description

It was reported to terumo cardiovascular that during pre cardiopulmonary bypass, an error "h/s is disconnected with the cuvette¿ occurred.The device was used without measuring (without replacing the cuvette) because there was not enough time.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 known impact or consequence to patient.The product was not changed out.Procedure completed successfully.

Manufacturer Narrative

The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample was microscopically inspected, and the magnet of the cuvette did not reveal any potential defect that would inhibit part functionality.The returned sample was found to have no difficulties connecting to the cdi 500, and the magnet strength was found to be within specifications.A retention sample from the same product code/lot number family was also evaluated and found to have no issues.A definitive root cause could not be determined; therefore, this event is not confirmed.This event is associate 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 3/8X3/8-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 ; 8002837866
• MDR Report Key: 6305436
• MDR Text Key: 66661202
• Report Number: 1124841-2017-00013
• 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,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

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: 07/31/2019
• Device Model Number: CV-6913
• Device Catalogue Number: N/A
• Device Lot Number: UK01
• Other Device ID Number: (01)00699753270121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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