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 04/27/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that out of box the temperature probe port was found to broken at the venous inlet of the oxygenator.No pt involvement as this occurred out of box.

Manufacturer Narrative

Terumo has rec'd the actual device for eval; however, the investigation has yet to be completed.Terumo plans on submitting a f/u report when the investigation is completed and more info 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): TERUMO CORP., ASHITAKA; 150
• Manufacturer Contact: eileen dorsey, ra manager ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3876063
• MDR Text Key: 4595005
• Report Number: 9681834-2014-00145
• 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: 04/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• 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: 130809
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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