MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1CX*FX05RW

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.A review of the device history records and product release decision control sheet of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.See mdr no.9681834-2017-00021 for the second device reported in this complaint.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported two damaged capiox devices when removing from the damaged packages.Follow up communication with the user facility reported the following information: there was no patient involvement.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the returned sample evaluation; provide the device return date in device available for evaluation.The actual device was returned to the manufacturing facility.Visual inspection revealed that the top side of the shipping cardboard box in which the actual samples were packed had been damaged.The shipping cardboard box was opened.One of the top lids that had been broken off its place was found to have been put on the top of the unit boxes packed in the shipping box.The broken top lid was removed.It was revealed that the two unit boxes set on the upper stage were found to have been broken on the top side.The two unit boxes set on the lower stage were confirmed to have no damage on them.Each product was unpacked from the unit box for further visual inspection.All four devices were confirmed to have no anomaly or breakage.From the state of damage observed on the boxes, it is likely that the actual sample was exposed to some load during transportation and became damaged.There is no evidence that this event was related to a device defect or malfunction and the exact cause for the reported event cannot be definitively determined.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6303577
• MDR Text Key: 66621745
• Report Number: 9681834-2017-00003
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• 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: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• 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 Catalogue Number: 1CX*FX05RW
• Device Lot Number: 160831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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