MAUDE Adverse Event Report: TERUMO CORPORATION ASHITAKA FX OXY W/HR & ART FILTER; BLOOD GAS OXYGENATOR

Model Number 1CX*FX25RW

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2015

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the actual device for evaluation; however the investigation has not yet been completed.Terumo plans on submitting a follow-up report when the investigation is completed and more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during prime, it was discovered that the temperature probe that is attached to the venous inlet was loose.No patient involvement as this occurred during prime.Product was 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 march 31, 2015.The actual sample was visually inspected upon receipt, during which no anomalies were found.A thermometry unit was connected to the affected thermistor probe, during which it was found that the thermistor probe moved from side to side.The sample was then x-ray fluoroscopically inspected and found to be fractured.The packing configuration of a retention sample was inspected, and it was confirmed that the thermistor probe does not come in contact with any packing materials.Review of the device history records revealed no anomalies.Although a definitive root cause could not be determined, it is likely that the sample was exposed to a force causing the thermistor probe to fracture.All available info has been placed on file in quality management for appropriate tracking, trending and follow-up.

Manufacturer Narrative

The actual device was returned to the mfg facility for eval.Visual inspection upon receipt did not find any defects or anomalies.Magnifying inspection of the thermistor probe on the venous blood inlet port did not find any defects or anomalies.A thermometry unit was connected to the thermistor probe.The thermistor probe was found to move from side to side.The thermistor probe was x-ray fluoroscopically inspected and found to have been fractured.The board was found not to have been damaged.The packing configuration was checked on the retention sample.The thermistor probe was found to be in the location where no packing material comes into contact with it.A review of the device history record and the product release decision control sheet of the involved product/lot# combination confirmed there were no production related problems or discrepancies in the inspection/test results.A review of the complaint files confirmed the involved product/lot# combination has not been reported previously.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined from the available information.It is likely that the thermistor probe was subjected to a force due to some factor(s) and became fractured.From the available information, however, it cannot be determined when and how the fracture has occurred on the actual sample.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Event Description

This report is being submitted as follow-up #2 for mfg report # 9681834-2015-00057 to provide the return sample eval results and to correct the date the manufacturer received the actual device.

Manufacturer Narrative

As stated in adverse event section this report is being submitted as follow up #3 for mfg report # 9681834-2015-00057.The follow up report that was sent on 6/11/2015 as follow up #1 was inadvertently labeled and should have been labeled as follow up #2.

Event Description

This report is being submitted as follow up #3 for mfg report # 9681834-2015-00057.The follow up report that was sent on 6/11/2015 as follow up #1 was inadvertently labeled and should have been labeled as follow up #2.

• Brand Name: FX OXY W/HR & ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka pref 418 ; JA
• Manufacturer (Section G): TERUMO CORP. ASHITAKA; 150 maimaigi-cho; fujinomiya city 150 ; JA 150
• Manufacturer Contact: robyn o'donnell, manager ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4652419
• MDR Text Key: 79094197
• Report Number: 9681834-2015-00057
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 1CX*FX25RW
• Device Lot Number: 140501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 10 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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