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

Model Number 3CX*FX15RW30C

Device Problem Misassembled (1398)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2018

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).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a yellow cap like on gas outlet was put on one of the suction ports where there should be a blue cap.No known impact or consequences to patient.Product was not changed out.Procedure was completed successfully.

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 on march 05, 2018.(b)(4).Without the returned device, a thorough investigation could not be performed.The provided pictures were reviewed and confirmed that all caps were in their locations.The yellow cap on the gas outlet port was appropriately in place and the caps on top of the reservoir were all appropriately in place.A retention sample was visually inspected and all caps were present and in their correct locations.They were also verified to be pushed on to provide an adequate seal.No anomalies were noted related to the reported event.Since the actual sample was not returned and the provided pictures could not confirm the reported event, the root cause for this event cannot be determined.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
• MDR Report Key: 7313699
• MDR Text Key: 101721953
• Report Number: 1124841-2018-00033
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: VM23
• Other Device ID Number: (01)00699753450783
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1