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

Catalog Number ZZ*CP50

Device Problem Material Separation (1562)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product-release deciison control sheet of the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the capiox cardioplegia was used pre-treatment.There was a broken vent cap on cpg set 1 piece.One set with very strong closed vented cap and during opening it broke up.Opening of the vented cap was possible only with exerting more traction and this was maybe the issue why the cap broken out inside of the entrance.The broken part remains inside and blocks the air leak - deaeration.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection of the actual sample revealed that the yellow cap connected to the air vent port had been fractured at the root, and a part of it had been connected inside the port.No fractured piece of the yellow cap was returned.Magnifying inspection of the side of actual air vent port did not find any anomaly including a crack.Magnifying and electron microscopic inspections of the fractured surface revealed: the air vent port was slightly deformed.The fractured surface of yellow cap was partially elongated.Simulation test: since the actual air vent port was slightly deformed, it was inferred that the yellow cap was strongly fitted due to some force.Therefore, the yellow cap was attached to a factory-retained product and applied shock force on it.As a result, the yellow cap was tightly fitted and was fractured (twisted off) at the root when removed.The fractured surface of yellow cap was partially elongated.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 likely that some force was applied to the yellow cap of air vent port, and the yellow cap was tightly fitted.However, since the fractured piece of yellow cap was not returned and could not be inspected, it was not possible to clarify when the force was applied.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: 12703178
• MDR Text Key: 279587987
• Report Number: 9681834-2021-00187
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Catalogue Number: ZZ*CP50
• Device Lot Number: 200710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2020
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 85 KG