MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RW

Device Problems Device Damaged Prior to Use (2284); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device; therefore, 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).

Event Description

The user facility reported to terumo cardiovascular that the oxygenator has a broken manifold. No patient involvement. During out of the box.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on november 4, 2016. (b)(4). The sample was not returned for evaluation. A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any damages or anomalies, specifically with the sampling manifold. A review of the device history record revealed no manufacturing anomalies. A definitive root cause could not be determined; therefore, this complaint is not confirmed. All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6080056
• MDR Text Key: 59230190
• Report Number: 1124841-2016-00381
• 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

• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2019
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: UD28
• Other Device ID Number: (01)00699753450110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial