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

Catalog Number CX-XRX50802

Device Problem Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number for the product code is not required.The actual device has been returned to the manufacturing facility for evaluation.Visual and magnifying inspections found a break which implied the actual sample was distorted and ripped off.Based on the complaint description, it is assumable that the actual sample was detached from the main body forcefully.This break seemed to have nothing to do with the reported issue.X ray fluoroscopic inspection did not reveal any anomalies such as a break on the lead wire.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found one other report of this nature from the same facility.See mdr number 9681834-2017-00161.There is no evidence this event was related to a device defect or malfunction.Since the actual sample was returned to (b)(4) in the broken state, it was not possible to complete an evaluation from the view point of its temperature determination performance.The exact cause of the reported event cannot be definitively determined based on the available information.(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 an unexpected value in the temp of the capiox device during a procedure.Follow up communication with the user facility provided the following information: the capiox device with lot number 170131 showed an unexpected value in the arterial temperature with some variation; the customer changed out 170131 to 170330; the issue was not solved, the customer found that when contact was made with the base of the cable jack the indicated values varied; and the customer continued the extracorporeal circulation successfully.

• Brand Name: CAPIOX FX 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: 6766418
• MDR Text Key: 81787105
• Report Number: 9681834-2017-00160
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• 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
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: CX-XRX50802
• Device Lot Number: 170131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• 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
• Treatment: SENKO CENTRIFUGAL BLOOD PUMP MACHINE