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

Catalog Number CX*FX25RW

Device Problem Break (1069)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted occupation- technologist 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.The product-release judgement record of the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that when they opened the capiox device sterilized package pre-treatment, there were no port caps on the blood inlet port.The perfusionist did not find the broken part in package.The patient was not harmed.

Manufacturer Narrative

The actual sample was received for evaluation and a photo was provided by the user facility.The picture of the actual sample during the event showed that the blood inlet port was fractured.The box in which the actual sample was packed at the time of arrival was confirmed that it was the box for the involved product code and lot# and, it was torn and crushed.From this state, it was not determined when the tear and the crush occurred.Visual inspection of the actual sample revealed that the blood inlet port had been fractured at the root.In addition, the water port and the gas port of the oxygenator had been deformed.No break, no deformity, or no other external anomaly was observed around the blood inlet port.The fractured blood inlet port was not returned for evaluation.The housing of the blood inlet port side was disassembled, then the root of the blood inlet port was inspected under magnifier.No crack, no deformity, or no other external anomaly was observed around the root of the blood inlet port.Magnifying inspection of the fractured section of the blood inlet port found that the fracture surface was smooth on the whole, and streaky pattern went out radially from the direction between the front side and the bottom side of the oxygenator.Magnifying inspection around the estimated central point of the radial streaky pattern found that wavy pattern went out from the same point.It was likely that an instantaneous load was exerted on the blood inlet port from the direction between the front side and the bottom side of the oxygenator.The fracture of the blood inlet port appeared to have started from the central point of the wavy pattern and developed radially.Review of the video that recorded the packing process of the involved product code/lot# combination confirmed that all the product of this lot had a blue cap attached to the blood inlet port.From this, it was conceivable that the blood inlet port of the actual sample was not fractured at the time of packing.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.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 was subjected to a shock load from the direction between the front side and the bottom side of the oxygenator and fractured.In addition, though the causal link with the fracture of the blood inlet port was unknown, the deformation of the water port and the gas port suggested that the actual sample was exposed to a shock load.Since no anomaly was noted in the manufacturing-related records or in the monitoring video in the packing process, it is likely that the actual sample was subjected to a shock load unexpectedly at some point during transportation or storage.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11077356
• MDR Text Key: 223801777
• Report Number: 9681834-2020-00267
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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: 07/31/2023
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 200821C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1