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

Catalog Number CX*RX25RW

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Establishment name: (b)(6) hospital.The actual device was received for evaluation.Visual inspection revealed that the unit box had been partially deformed, implying that the unit box had been exposed to some force.The actual sample was unpacked and subjected to visual inspection.The sampling line tube was found to have fractured at the joint with the oxygenator blood outlet port.One of the components of the support arm was found to have come off its place.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 air bubbles trapped 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 implies that the fracture developed in the direction of the streak pattern.The sampling line tube was cut vertically at one point and the cut cross-section was inspected under magnification.There was no unevenness in the wall thickness.The outside and inside diameters of the tube were confirmed to be equivalent to those of the current product sample.Review of the temperatures in (b)(6) from august 2018 when the actual sample was manufactured to april, 2019 when this complaint occurred found that the lowest temperature went down below zero in some months.Reproductive testing was performed on more than one test product sample.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, some of the tubes became fractured at the connections to the ports.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the actual sample was cooled down due to a low temperature during transportation in a cold season 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, 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.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.(b)(4).

Event Description

The user facility reported that after unpacking the involved capiox rx25 device, the perfusionist found that the line that should be connected to the blood outlet, was broken.The event occurred pre-treatment.The procedure outcome and patient impact 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: 8535695
• MDR Text Key: 142641186
• Report Number: 9681834-2019-00062
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 180830C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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