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

Model Number 6913

Device Problem Connection Problem (2900)

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

Event Date 12/05/2015

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.(b)(4).

Event Description

The user facility reported to a terumo affiliate that during cardiopulmonary bypass, after calibration, the user received an h/s disconnect error.This event is associated with a voluntary safety alert initiated by terumo: 1124841-12/08/2015-004-c.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 december 23, 2015.(b)(4).The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The sample was microscopically inspected, and the magnet of the cuvette did not reveal any potential defect that would inhibit part functionality.The sample was found to have no difficulties connecting to the cdi 500, and the magnet strength was found to be within specifications.A definitive root cause could not be determined; therefore, this event is not confirmed.Although this event is not confirmed, other occurrences of this issue have determined that the root cause of the failure was defective magnets that have a lower magnetic strength than normal.These magnets are manufactured by an outside supplier, (b)(4).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
• 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: 5323964
• MDR Text Key: 34277023
• Report Number: 1124841-2015-00347
• 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,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

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
• Device Expiration Date: 04/30/2018
• Device Model Number: 6913
• Device Lot Number: TF04
• Other Device ID Number: (01)00699753270152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2015
• 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