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

Model Number 3CX*FX15RE30C

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Patient Involvement (2645)

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 code.(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 there was an incorrect shipment.Fx25 was ordered and fx15 was shipped and received.No patient involvement.

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 october 27, 2017.The returned sample was visually inspected.It was confirmed that fx15 units were shipped within a 4 piece fx25rec outer carton.The dhr was reviewed to trace the labeling of the inner and outer cartons.The attached 1 piece and 4 piece label on the manufacturing order (dhr) were correct.Documentation shows appropriate labeling was utilized for packaging before being sent out for sterilization, and released.A definitive root cause could not be determined; however, it is likely that a shipping issue occurred after final release causing product to be removed from the case prior to being delivered to the customer.Review of the labeling and shipping records of the affected products indicates that the product was manufactured several months apart and was shipped directly to a distribution center from the sterilization facility, then the product was shipped to a perfusion service organization prior to shipment to the medical facility.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 CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6985224
• MDR Text Key: 91237812
• Report Number: 1124841-2017-00224
• 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
• Report Date: 01/05/2018

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: 06/30/2020
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: VH10
• Other Device ID Number: (01)00699753450806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2017
• 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