MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP STERILE FX15REC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE30C

Device Problem Incorrect Device Or Component Shipped (2962)

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

Event Date 02/27/2018

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).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, a device with different part number was received no consequence to the patient.

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 16, 2018.(b)(4).The actual sample was not returned; however, a photo was provided which confirmed the observation.Documentation shows appropriate labeling was utilized for packaging before being sent out for sterilization, and released.The distribution center was notified for further investigation.It was determined that there was an order being processed at the same time for both of the part numbers and the two items being similar in appearance and the parts most likely got transposed during order processing.There was a failure in procedure execution as the picker did not pick the correct item and the packer nor shipper noted the error during their verification.The root cause was determined as the procedure was not followed as written.To prevent the future occurrences, the responsible associates will be retrained on the procedures.Also, the facility is improving the spacing of products that will allow better segregation for order processing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7344892
• MDR Text Key: 103158285
• Report Number: 1124841-2018-00045
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: UK01
• Other Device ID Number: (01)00699753450806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1