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

Catalog Number CX-FX15RE40

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual device was returned for evaluation.Visual inspection upon receipt found that the lock adapter had come off the male connector and the female connector was attached to the male connector and fixed to it with an adhesive tape.There was not any other anomaly, such as a break, on the remainders of the actual device.Magnifying inspection did not find any anomaly, including deformation, on each component that was inspected under magnification.The male and female components were rinsed but the adhesive would not be removed from their surface completely.A factory-retained sampling system was connected to a female connecter and the lock adapter was tightened up with the application of excessive torque force.It was found that the lock adapter could come off the male connecter.A review of the device history record and the product release decision control sheet of the reported product code/lot number combination was conducted with no findings.The ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation result, it is likely that the lock adapter of the actual device was subjected to excessive torque force and came off its place.From the state of the actual device, however, the definitive cause cannot be determined.(b)(4).

Event Description

The user facility reported that when they unpacked the actual sample and gave additional tightening to the lock adapters attached to the both ends of the sampling system during set-up in the regular manner.During some further manipulations for preparation, when the customer tried to remove the female connecter connected to the male connecter on the arterial side of the sampling system, the lock adapter attached to the male connecter on the sampling system came off together with the female connecter.The customer connected the female connecter to the male connecter directly, fixed them with an adhesive tape and continued to use the actual sample till the end of the procedure.No change out of the actual sample.No blood loss.

• 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: mark vornheder ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8371949
• MDR Text Key: 138804997
• Report Number: 9681834-2019-00016
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CX-FX15RE40
• Device Lot Number: 180409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• 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