MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1ZZ*FX15EA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2018

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.Udi - not required, this product code is a bulk product.Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(4).The actual device was not returned for evaluation, however a photograph of the actual sample was returned.Therefore, the investigation was based on the evaluation of user facility information, the returned photograph of the actual sample and evaluation of a retention sample from the reported product code/lot number combination.A review of the provided photo noted that the purge line tube had been fractured at the joint to the port on the oxygenator module.Visual inspection of the retention sample revealed no defects.The retention sample was built into a circuit with tubes and circulated with colored saline solution.There was no leak at the joint of the purge line tube to the port.The investigation result verified that the retention sample was the normal product with no anomaly on the purge line tube.With no return sample, the configuration of the fracture on the actual sample provided by the photograph can not be seen.From the available information, the cause of this complaint cannot be definitely determined.(b)(4).

Event Description

The user facility reported that during prime it was found that the purge of the oxygenator was not glued properly to the outlet.The product was changed out.It was reported that the surgery was completed successfully.No blood loss was reported.

• Brand Name: CAPIOX FX 15 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: 7258703
• MDR Text Key: 99895716
• Report Number: 9681834-2018-00006
• Device Sequence Number: 1
• Product Code: DTZ
• 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
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2019
• Device Catalogue Number: 1ZZ*FX15EA
• Device Lot Number: 161125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2016
• 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