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 04/28/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corporation that visible cracking on the top of the reservoir at the venous inlet port was discovered out of the box.No patient involvement as this occurred out of box.

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 become available.For this reason, terumo referenced evaluation conclusion.(b)(4).

Manufacturer Narrative

The actual device was visually inspected upon receipt revealing breakage and cracking in the reservoir lid.The damage, located in the area around the venous port, is consistent with an applied external force as this is the most external point in the packaged unit.Since the product is 100% visually inspected and leak tested during the manufacturing process, the reported damage is most likely due to excessive force post manufacturing; however the cause of the damage is unknown.A review of the device history record revealed there were no production related anomalies.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• 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 (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: robyn o'donnel, quality mgr. ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4777976
• MDR Text Key: 5813674
• Report Number: 1124841-2015-00160
• 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: 04/28/2015

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: 09/30/2017
• Device Model Number: 3CX*RX25RE
• Device Lot Number: RM20
• Other Device ID Number: 0100699753450103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• 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