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

Catalog Number CX*RX15RW30

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - no patient involvement.Age & date of birth - no patient involvement.Sex - no patient involvement.Weight - no patient involvement.Ethnicity - no patient involvement.Race - no patient involvement.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was returned for evaluation.Visual inspection revealed that the purge line tube's elbow connector that is to be connected to the reservoir had been completely fractured.Magnifying and electron microscopic inspections of the fracture cross-section of the elbow connector did not find any embedded foreign particle or entrainment of air bubbles which would have contributed to the generation of the fracture.On the surface of the fracture cross-section some streaks were noted to have been generated.From these findings, it is assumable that the fracture started at one point and developed further in the direction the streams show.Reproductive testing was performed on a factory-retained elbow connector was connected to the reservoir and instantaneous shock force was applied to the elbow tube from above.The elbow tube got fractured in the similar manner as the actual sample at the same position as that on the actual sample.Magnifying and electron microscopic inspections of the fracture cross-section of the elbow connector found that some streaks similar to those on the actual sample had been generated on the fracture cross-section.A review of the device history record and the product release decision control sheet of the reported product code/lot number combination was conducted with no findings.Ifu reference: 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 result, it is likely that the elbow connector of the actual sample was exposed to shock force which exceeded the strength limit of this component form above in the state of being connected to the reservoir, resulting in the reported fracture.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 a fracture was found on the recirculation line joint, before priming the capiox rx15 device.It occurred pre-treatment, and the patient was not harmed.The procedure 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: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7989766
• MDR Text Key: 124526705
• Report Number: 9681834-2018-00193
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051997
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 180316C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• 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