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

Model Number 1CX*FX05RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the temperature port broke.*no patient involvement as this occurred during setup.*the product was not used.*the 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 information becomes available.(b)(4).

• Brand Name: BABY FX OXY W/HR & ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): ASHITAKA FACTORY OF TERUMO CORP.; 150 maimaigi-cho; fujinomiya, shizuoka ; JA
• Manufacturer Contact: eileen dorsey, mgr. ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3898955
• MDR Text Key: 4671677
• Report Number: 9681834-2014-00149
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• 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: 05/07/2014

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: 07/31/2016
• Device Model Number: 1CX*FX05RE
• Device Lot Number: 130808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2013
• 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