MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR WEST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RW

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation of the device the complaint was confirmed.The complaint sample was returned and visually inspected.It was found that one of the cardiotomy ports on the top of the reservoir, the last in the row, was dented the reservoir lid was slightly removed from the reservoir.No other damages were noted anywhere else on the device.A retention sample from the same product code/lot number combination was obtained for visual inspection and it was confirmed to have no damages and be within specification.Due to the way the port was dented inward on the returned sample, it suggests that an extreme external force had been placed on the product.All units are 100% visually inspected in-process both prior to sealing and while packaging the product.It is likely that an extreme external force was placed on the cardiotomy port at some point after final release of the product causing the inward damage to the port and the lifting of the reservoir lid; however, it is unknown how or when this damage was caused.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during setup, it was discovered that one of the caps of the inlet ports on the top of the reservoir appeared to be melted and pushed towards another port.No patient involvement as this occurred during setup.Product was changed out.Surgery was completed successfully.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5500484
• MDR Text Key: 40328251
• Report Number: 1124841-2016-00107
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 3CX*RX25RW
• Device Lot Number: RH21
• Other Device ID Number: (01)00699753450110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2014
• 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