MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX25RW

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device has not yet been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no relevant findings.A search of the complaint file found no previous report of this nature with the involved product code/lot number combination.(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 a break in the capiox device.Follow up communication with the user facility confirmed the following information: upon receiving the oxygenator device damaged was noted without opening the package; and there was no patient involvement.

Manufacturer Narrative

It was initially reported the actual device was available for evaluation, however confirmation was received that the sample was no longer available.The actual device was not returned for evaluation.An evaluation of the retention sample was performed.Visual inspection revealed no anomalies.The retention sample was of normal product.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.However, based on the reported state of occurrence, it is possible that the actual sample was exposed to excessive shock force after having been taken out of the box and the oxygenator module then broke.The ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.

Event Description

Additional information was received on january 16, 2018.The oxygenator groove of the actual sample had been broken.

• Brand Name: CAPIOX RX OXYGENATOR
• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6961103
• MDR Text Key: 90634519
• Report Number: 9681834-2017-00225
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: (01)04987350769572(17)200229(10)170323
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 170323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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