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

Model Number 3CX*RX25RW

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the 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 when more information becomes available.For this reason, terumo references evaluation conclusion.(b)(4).Results code: results pending completion of evaluation.Conclusions code: conclusion not yet available - evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass procedure, during setup, the perfusionist found some sticky glue-like substance on the water import on the oxygenator.No patient involvement.Product was changed out.Surgery completed successfully.

Manufacturer Narrative

The returned sample was visually inspected and it was found that a sticky, glue-like substance, was present on both the water inlet and outlet ports and gas inlet of the oxygenator.The sample was then sent to an outside lab for analysis on the materials' properties, finding it to be a significant match to poly aba block, which is used in hot melt adhesives.This material is not used in any of terumo's manufacturing or testing processes; therefore, it is unknown when or how this material was introduced to the oxygenator.A review of the device history record revealed no manufacturing anomalies.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 SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6375865
• MDR Text Key: 69020542
• Report Number: 1124841-2017-00036
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: UM03
• Other Device ID Number: (01)00699753450110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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