MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS STERILE FX15RE OXY W/ 3L RESERVOIR; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE30

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual 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 more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems that out of box, they received a case with 2 missing oxygenators.No patient involvement as this occurred out of box.

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 december 23, 2015.(b)(4).The product was not returned for evaluation, nor were the shipping records or documentation regarding the receipt of the product at the user facility.The device history records were reviewed in detail to trace the quantity of product produced.It was confirmed that the there was traceability for all of the product produced during this manufacturing work order; therefore, it is not likely that a case would have been packaged and shipped with two products missing.A definitive root cause could not be determined and the event was not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX15RE OXY W/ 3L RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5323950
• MDR Text Key: 34277266
• Report Number: 1124841-2015-00340
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140774
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 3CX*FX15RE30
• Device Lot Number: TK24
• Other Device ID Number: (01)00699753450448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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