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

Model Number 1CX FX15RW30

Device Problem Sharp/jagged/rough/etched/scratched (2594)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems that during cardiopulmonary bypass the po2 levels ranged from 150 to 386 with the fio2 at 100%.No known impact or consequence to patient.The product was not changed out.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: FX OXY W/HR AND ART FILTER
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORP. ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuoka ; JA
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150
• Manufacturer Contact: robyn donnell, quality mgr ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4001068
• MDR Text Key: 21311913
• Report Number: 9681834-2014-00209
• 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: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1CX FX15RW30
• Device Lot Number: 152506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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