MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RE

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has 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.For this reason, terumo referenced evaluation (b)(4).(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems that during out of box, customer received an oxygenator with a sterilization tag on the box that says product awaiting eto sterilization.Customer believes that the product has not been sterilized yet.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 february 1, 2017.Method: actual device evaluated; visual inspection; storage and shipment review.Results: shipping problem.Conclusions: human factors issue.The returned sample was visually inspected, during which it was found that a sterilization tag was still present on the outer carton.The shipment of this product was traced and it was determined that the carton was sent to sterilization from (b)(4) after manufacturing, with the sterilization tag present.After sterilization, the product was sent directly to the distribution center in tennessee, where the tag was not removed.The product was then delivered to the customer with the tag still remaining on the carton.When the product was shipped from sterilization to the distribution center directly, the awaiting sterilization tag should have been removed by an associate prior to shipping to the customer.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6294958
• MDR Text Key: 66318381
• Report Number: 1124841-2017-00010
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• 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: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: UN07
• Other Device ID Number: (01)00699753450103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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