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 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was returned for evaluation.Visual inspection revealed that the original unit box containing the actual sample had been deformed.Visual inspection of the actual sample revealed that an unknown tube had been connected to the sampling line port on the oxygenator module.The tube was removed and the sampling line port was subjected to visual inspection.It was found that the sampling line tube had been fractured at the joint with the port.It is most likely that this damage was the cause of the reported leak.Magnifying and electron microscopic inspections of the cut cross-section of the broken sampling line tube revealed that the smooth surface and rough surface existed there, with the generation of some streaks noted on the smooth surface.The streaks imply that the break has developed on the tube in the direction the streaks run.Reproductive testing was performed.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.Review of the temperatures in (b)(6) from september 2018 when the actual sample was manufactured to january, 2019 when this complaint occurred found that the lowest temperature went down below zero in some months.With this information being taken into account, the reproductive test was performed with the test conditions being set arbitrarily.A test product sample, after having been cooled down to minus 10 oc, 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.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.Ifu states: do not use an oxygenator and reservoir that leaks.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is most likely that that actual sample leaked at the sampling line tube which had been fractured off its joint to the port on the oxygenator module.Based on the state of the fracture surface of the actual sample and the reproductive test result, it is assumable as a cause of the fracture 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 being handled inattentively during transportation or storage.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 leakage with the involved capiox rx25 device.During priming, the perfusionist found the leakage and fracture at the joint of sampling line with the oxygenator sampling port.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: mark vornheder ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8330510
• MDR Text Key: 138940465
• Report Number: 9681834-2019-00011
• 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: Physician
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 180907C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2018
• 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