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

Model Number 1CX FX15RE30

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular sys that prior to cardiopulmonary bypass, during prime, the connection at the 3/8" reducer/outlet of the reservoir leaked.The user rigged the connection by adding a piece of smaller tubing to stop the leak; therefore, the product was not changed out.No pt involvement as this occurred during prim.The product was not changed out.No surgery was completed successfully.

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 info becomes available.(b)(4).

• Brand Name: FX OXY W/HR & ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORP, ASHITAKA; 150 maimaigi-chu; fujinomiya, shizuoka, prefecture 418 ; JA
• Manufacturer (Section G): TERUMO CORP., HITAKA; 150 maimaigi-cho; fujinomiya, shizuoka ; JA
• Manufacturer Contact: eileen dorsey, mgr ; 125 blud ball rd; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3963314
• MDR Text Key: 4625074
• Report Number: 9681834-2014-00165
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/12/2014

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: Other
• Device Expiration Date: 08/31/2016
• Device Model Number: 1CX FX15RE30
• Device Lot Number: 130926
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2013
• 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