MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX CARDIOPLEGIA; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Catalog Number ZZ*CP50

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

The user facility reported the capiox cardioplegia device was used pre-treatment.The device of connection was leaking.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The movie provided by the user showed that the leak was coming from the side of the air vent port.A review of the device history record and product-release decision control sheet of the involved product code/lot# combination was conducted with no findings.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation and the user provided a movie.Review of the provided movie showed that the leak was coming from the side of the air vent port.Three-way stopcocks, three pieces in total, were attached to the air vent port and the pressure monitor port of the actual sample.These three-way stopcocks had not been installed when the product was released from the manufacturer.Visual and magnifying inspection of the actual sample revealed that the air bent port had been cracked from the edge.Based on experience, it was likely that the crack in such a form occurred due to over-tightening, chemical crack, or interaction of both factors.The streak that had occurred lengthwise near the crack was confirmed to be a parting line occurred at the joint between molds in the injection molding process and not a crack.A factory-retained cap was attached to the air bent port of the actual sample, and then physiological saline solution was flowed by head into the actual sample.As a result, leak from the crack was observed.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It was confirmed that the actual sample had the crack leading to the leak.This product is subjected to the leak test with the caps for inspection attached.As for the caps for the products, they are tightened to the quantitatively controlled torque after the leak inspection, and then the products are shipped from the factory.Since the specifications of the circuit products and the customer's usage condition were unknown, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX CARDIOPLEGIA
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 13000505
• MDR Text Key: 282278556
• Report Number: 9681834-2021-00224
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: GG
• PMA/PMN Number: K982467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: ZZ*CP50
• Device Lot Number: 200409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2020
• 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