MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX05; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX05RW

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Age & date of birth - age: reported to be (b)(6) years.Date of birth: requested, not provided.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k) - k130280.The actual sample was received for evaluation.Visual and magnifying inspections of the actual sample revealed that the blood inlet port had been crushed from the outside to the inside.Therefore, it was considered that some sort of load was applied to the inlet port.There was not any other anomaly, such as a breakage, in the remainder of the actual sample.Visual and magnifying inspections of the blue cap that had been attached to the inlet port confirmed it had no anomaly in the appearance such as deformity.Therefore, it was likely that the blood inlet port was exposed to some load after the blue cap was removed from it.A factory-retained sample from the involved product code was checked for the positional relationship between the oxygenator and cushioning material when the oxygenator was contained inside the unit box.It was confirmed that the blood inlet port was not in contact with the cushioning material.Reproductive testing was performed, and the blood inlet port of an oxygenator sample was hit by a hard object.As a result, the blood inlet port became crushed inward.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.If the product is dropped during set-up , do not use it.Replace with another device.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 is likely that the blood inlet port of the actual sample was hit by a hard object and deformed.From the available information, however, it is difficult to determine the cause of occurrence of the problem.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox fx05 oxygenator inlet was damaged pre-treatment.

• Brand Name: CAPIOX FX05
• Type of Device: OXYGENATOR, 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: theresa mussaw ; reg. no. 2243441; 265 davidson ave suite 320; somerset, nj ; 2837866718
• MDR Report Key: 10470485
• MDR Text Key: 242646510
• Report Number: 9681834-2020-00172
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071572
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 191213C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2019
• 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 Weight: 14