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

Model Number 3CX*FX25REC

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device; 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 customer reported to terumo cardiovascular that the account should of received a case of item (b)(4), instead they received a case of (b)(4) which is the incorrect item. The outer box and the product show that the incorrect item was shipped. 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, 2016. Upon further investigation of the reported event, the following information is new and/or changed: (device availability), (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information), (device evaluation anticipated). A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references (b)(4). All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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. (b)(4). The sample was returned for evaluation. The shipping of this product was traced in order to determine how the incorrect product had been placed into the outer box. It was found that a separate customer had originally received the product 3cx*rx25re in error. At this time, the customer must have removed the incorrect rx product, and placed it into an fx25 outer box. This box with the rx product was returned to the (b)(4) distribution center. The (b)(4) received the returned product as 3cx*fx25re uh11, as this is what the outer box stated, and noted in the system that the incorrect product was returned, and rx25 product should have been returned, without opening the outer box to confirm the one-piece boxes within. The returned product was placed back into inventory as fx product, and then was shipped out to the reporting customer. That is when the customer opened the outer fx box and discovered that rx25 product was shipped within the outer box. 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: 6062043
• MDR Text Key: 58604116
• Report Number: 1124841-2016-00366
• 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: distributor,user facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2019
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: UH11
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial