MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number ZZ*FX15WA

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no findings.(b)(4).

Event Description

The user facility reported during set up, the quick connect (pigtail) line was found sheared off on the involved capiox oxygenator.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d10 and the completed investigation.The actual sample was received for evaluation.Visual inspection upon receipt found that the sampling line tube had fractured at the joint with the oxygenator blood outlet port.There was not any other anomaly, such as a crack, on the remainders of the device.Magnifying and electron microscopic inspections of the fracture cross- sections of the sampling line tube confirmed there was not any anomaly on the surface that could have been a trigger of the generation of the fracture with no embedded foreign substance or entrainment of air bubbles in the material.The surface was in the smooth state on some part and in the rough state on the other part.On the smooth part some streaks were found to have been generated.This streak pattern suggests that the fracture occurred at one point, and developed in the direction of the streak pattern.The annual average temperature was checked in the area of which the event occurred, and it was found that in some months, the temperature goes down to below zero.The state of the fracture on the actual sample is experientially known to be consistent with the state when the tube has been damaged as a result of exposition to some shock force under a cold temperature.Based on the hypothesis that the actual sample was exposed to some shock force under a low temperature, the reproductive test was performed with the test conditions being set arbitrarily.A test product sample, after having been cooled down to minus 10 degrees c, was dropped from 1.5m high in the state of packed in the box in the normal manner.As the result, the tube got fractured.There is no evidence that this event was related to a device defect or malfunction.Based on the state of the fracture surfaces of the actual sample and the reproductive test result, a likely cause of the event is that the actual sample was cooled down due to a low temperature during transportation and/or due to the storage environment and that, in this state, it was subjected to some excessive shock force due to the way of handling during transportation or storage, resulting in the reported fracture of the tube.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX15 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
• MDR Report Key: 7675137
• MDR Text Key: 113639794
• Report Number: 9681834-2018-00128
• Device Sequence Number: 1
• Product Code: DTZ
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: ZZ*FX15WA
• Device Lot Number: 160728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1