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

Catalog Number CX*RX25RW

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).The actual sample was received for evaluation.Visual inspection revealed that the sampling line tube had fractured at the joint with the sampling line port on the reservoir.It was also found that the oxygenator module had come off the support arm.Magnifying and electron microscopic inspections of each fracture cross- section of the 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 tube material.The surface was in the smooth state on some part and in the rough state on other part.On the smooth part some streaks were found to have been generated.This streak pattern implies that the fracture occurred at one point and developed in the direction of the streak pattern.Review of the temperatures in (b)(6) from (b)(6) 2018 when the actual sample was manufactured to (b)(6) 2019 when this complaint occurred found that the lowest temperature went down below zero in some months.Reproductive testing was performed based off of this information.Multiple product test samples, after having been cooled down to minus 10 oc, were dropped from 1.5m high in the state of packed in the box in the normal manner.As the result, the tubes of some of the samples became fractured.Review of device history record and product release decision control sheet of the involved product/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.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results 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 being handled inattentively during transportation or storage, resulting in the reported fracture of the tube.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 during priming of the involved capiox device, the perfusionist found that the joint was broken between sampling line with blood inlet of reservoir.The procedure and patient outcome was reported to be unknown.

• Brand Name: CAPIOX RX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8468779
• MDR Text Key: 140428141
• Report Number: 9681834-2019-00044
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 181010C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• 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