MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1CX*FX25E

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age and date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, (b)(4) has been referenced in the conclusions section of evaluation codes.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 findings.(b)(4).

Event Description

The user facility reported that during prime, potting substance / material leached into fiber bundle causing micro air.The product was changed out.The surgery was completed successfully.It was reported that there was no blood loss.There was no impact to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section to state the device is not available for evaluation and provide the completed investigation results.It was initially reported that the device was available for evaluation, however, it has been confirmed that the device is not available for evaluation.Therefore, the investigation was based on the evaluation of the user facility information and evaluation of a retention sample from the reported product code/lot number combination.Visual inspection revealed no defects.The retention sample was built into a circuit with tubes and colored saline solution was circulated in the blood phase.No generation or entrance of an air bubble was noted.Colored saline solution was filled in the blood phase.With the blood outlet side clamped, the blood phase was pressurized from the blood inlet port side at 2kgf/cm2, while the retention sample was observed for a leak.No leak was confirmed.The inspection of the retention sample verified that it was the normal product, not presenting any anomaly, such as insufficient filling or a break.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• 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: 7185394
• MDR Text Key: 97789817
• Report Number: 9681834-2017-00265
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071494
• 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: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1CX*FX25E
• Device Lot Number: 170824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• 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