MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. FX25W PRESCRIPTIVE OXY SUB; BLOOD GAS OXYGENATOR

Model Number CXOT163

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2017

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, the temperature well is missing.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 fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on june 6, 2017.Upon further investigation of the reported event, the following information is new and/or changed: (additional device information - added exp date) (date received by manufacturer) (indication that this is a follow-up report) (follow-up due to additional information and device evaluation) (device evaluated by manufacturer) (device manufacture date) the returned sample was visually inspected.It was confirmed that the thermistor on the oxygenator was missing, with no evidence of chemical residue within the port.It is likely that the thermistor had been inserted into the port of the oxygenator, but never dipped into the chemical to bond it into the port, allowing it to come loose and not be present at the time of use.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: FX25W PRESCRIPTIVE OXY SUB
• Type of Device: BLOOD GAS OXYGENATOR
• 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: 6613810
• MDR Text Key: 76728810
• Report Number: 1124841-2017-00101
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

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 Model Number: CXOT163
• Device Catalogue Number: N/A
• Device Lot Number: VA30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 06/15/2017
• Supplement Dates FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• 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