MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR; BLOOD GAS OXYGENATOR

Catalog Number CX-FX25RE

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

The user facility reported sampling line separation in the capiox fx25 device.Follow up communication with the user facility reported the following information: the capiox device was being prepared for priming prior to the operation.The customer corrected the position of the oxygenator.The sampling line tube was identified as fractured.There was no patient involvement.The initial procedure was completed successfully.

Manufacturer Narrative

Device sustained shock during shipping and /or handling.The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt confirmed the customer's observation.The sampling line tube was noted to have been fractured off at the joint to the female connector.Magnifying inspection of the fracture cross-sections revealed smooth area and rough area on the surfaces.Electron microscopic inspection of the fracture cross- sections revealed the generation of some radial streaks starting at one point on the smooth surface.On the rough surface, the evidence of elongation was observed.These findings imply that the fracture started at one point and developed toward the center.Subsequently, the tube was completely fractured finally by a pulling force.The sampling line tube was cut at a point adjacent to the fracture for dimensional inspections.It was verified that the dimensions are comparable to the normal product.Simulation testing was conducted.A normal product sample of the involved product code pulled from the current production run was left under a low temperature of 4°c.Subsequently a shock force was applied to the sample.The tube got fractured, presenting the smooth surface on the fracture cross-section which was very similar to that of the actual sample.A review of the device history record and shipping inspection record of the involved product/lot number combination confirmed there were not any indications of production related anomalies or discrepancies in the inspection result.A search of the complaint file did not find any report of this nature with the involved product/lot number combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the available information, the appearance of the involved sample is most consistent with the actual sample being subjected to an excessive shock force generated due to inattentive handling during transportation under a cold temperature and got a crack at the joint between the sampling line tube and the port.Subsequently it was exposed to a pulling force during set up, resulting in the reported fractures on the tube.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).

• Brand Name: CAPIOX RX25 OXYGENATOR/RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4761916
• MDR Text Key: 5783199
• Report Number: 9681834-2015-00071
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2015,05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: CX-FX25RE
• Device Lot Number: 140908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/14/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2015
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• 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