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

Model Number 1CXFX25RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corp.That the oxygenator gas out port appeared to the deformed and was discovered out of box.No pt involvement as this occurred out of box.

Manufacturer Narrative

Terumo has received the actual 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 more information becomes available.(b)(4).

Manufacturer Narrative

This report is being submitted as follow-up #1 for mfr.Report # 9681834-2015-00092 to provide the evaluation results of the returned sample and to correct the date the manufacturer received the actual device.The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt confirmed the gas out port had been deformed into a crushed shape.There was no other visible anomalies or defects observed on the device.The wall thickness of the housing was measured on the segment adjacent to the gas out port and confirmed to meet manufacturer specifications.No anomalies or defects were found.A reproductive test was conducted: the gas out port of a current product sample was exposed to a shock force.Damage similar to that seen on the actual sample was duplicated on the current product sample.A review of the device history record and the product release decision control sheet of the involved product/lot number 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 number 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 gas out port on the actual sample was subjected to a shock force after the actual device had been removed the unit box.It cannot be determined, however, when and how the actual sample was subjected to the shock force.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 #1 for mfr.Report # 9681834-2015-00092 to provide the return sample evaluation results and to correct the date the manufacturer received the actual device.

Manufacturer Narrative

This report is being submitted as follow up # 2 to correct the product that was initially reported in model/lot #.The correct product code is cx*fx25e.

• Brand Name: FX OXY W/HR & ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORP., ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuoka 418 ; JA 418
• Manufacturer Contact: robyn o'donnell, qlty mgr ; 125 blue ball road ; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4777996
• MDR Text Key: 5813672
• Report Number: 9681834-2015-00092
• 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
• Report Date: 04/28/2015

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: 02/28/2017
• Device Model Number: 1CXFX25RE
• Device Catalogue Number: CX*FX25E
• Device Lot Number: 140305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 13 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2015; 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• 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