MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corp that prior to cardiopulmonary bypass, during setup, the housing that attaches the membrane to the reservoir was broken.No pt involvement as this occurred during setup.Product was not used.Surgery was completed successfully.

Manufacturer Narrative

Terumo has not received the actual device for eval; therefore, the investigation has yet to be completed.Terumo plans on submitting a f/u report when the investigation is complete and more info becomes available.(b)(4).Conclusions: conclusion not yet available, eval in progress.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: eileen dorsey, mgr ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3959768
• MDR Text Key: 4612100
• Report Number: 1124841-2014-00095
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2014

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: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 3CX*RX25RE
• Device Lot Number: RC24
• Other Device ID Number: (01)00699753450103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/06/2014
• Initial Date FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2014
• 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