MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the arterial temperature connector loose when attaching temp probe.No leaks reported.No patient involvement as this occurred during prime, product was changed out, procedure was completed successfully.

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 march 17, 2017.(b)(4).The returned sample was visually inspected.It was found that the thermistor on the oxygenator was broken.The external portion of the thermistor appeared to have sheared off of the port or insert, which remained within the oxygenator port.A retention sample from the same product code / lot number combination was visually inspected and confirmed to have no damages.The thermistor was properly attached to the oxygenator port.A review of the device history record revealed no manufacturing anomalies.All capiox units are 100% visually inspected at several points in the production process.It is likely that the thermistor was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined all available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25RWC W/ RES
• 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: 6413193
• MDR Text Key: 70226036
• Report Number: 1124841-2017-00041
• 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: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: UE11
• Other Device ID Number: (01)00699753450837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• 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