MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2017

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.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, during setup, the yellow cap on top of cardiotomy in the venous inlet was broken off and the internal portion was still in the port.No patient involvement.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).Visual inspection was performed on the actual sample upon receipt, during which it was found that one of the non-vented yellow caps of the curved venous inlet port was broken.The stem of the cap still remained within the luer port and the luer port had a slight chip along the top portion.Additionally, the reservoir housing had large cracks on the reservoir lid surrounding the venous inlet port location.A retention sample from the same product code and lot number combination was visually inspected and found to have no damages or anomalies, specifically with the reservoir lid and the caps on the curved venous inlet port.All reservoirs are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to the caps and reservoir.It is likely that the cap and reservoir lid were 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.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6947022
• MDR Text Key: 90239517
• Report Number: 1124841-2017-00206
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• 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,Followup
• Report Date: 11/30/2017

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: 12/31/2019
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: VA02
• Other Device ID Number: (01)00699753450783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 10/11/2017; 11/22/2017
• Supplement Dates FDA Received: 10/26/2017; 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2017
• 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