MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX05 OXYGENATOR

Catalog Number CX-RX25RE

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2014

Event Type  malfunction  

Event Description

The user facility reported breakage of the sampling system (stopcocks) on the cx-rx25re capiox device.Follow up communication with the user facility reported: (1) when the oxygenator in question was taken out from its unit box and set up to a holder, it was noted that the sampling system of multiple stopcock was detached from the oxygenator with a fracture at the joint between the stopcocks; (2) the involved oxygenator was not used and the operation was continued with a new oxygenator capiox rx25; (3) the procedure was completed successfully; and (4) there was no harm to the patient.

Manufacturer Narrative

The actual sample was returned to the manufacturing facility for evaluation.Visual inspection upon receipt confirmed the customer's observation.The male luer port of the blue three-way stop cock was noted to have been fractured off at the end of the joint bonded with the yellow three-way stop cock.There was no trace of the application of excessive amount of the solvent.Electron microscopic inspection of the fracture cross-section of the male luer lock of the blue three-way stopcock the surface was in the smooth state with some streaks spreading out from the side of the base of the sampling system in the upward direction.Reproductive testing was conducted.The sampling system on a current product sample was lifted up by the joint between the yellow three-way stopcock and blue three-way being help.The sampling system got fractured at the location similar to that on the actual sample.Electron microscopic inspection of the fracture cross-section revealed the state very similar to that on seen on the actual sample.Review of the dhr and the shipping inspection record of the involved product/lot# combination confirmed there were no production related problems.A search of the complaint file found no previous report of this nature with the involved product/lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although an exact cause cannot be determined based on the available information it is likely that after the actual sample was unpacked, its sampling system was held at the joint between the yellow three-way stopcock and the blue three-say stopcock and lifted up, where due to the principle of leverage a bending force was concentrated on the end of the female connector, resulting in the reported fracture.This information is being documented in the mdr report due to issues with esubmitter.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).

Manufacturer Narrative

This report is being submitted as follow-up #1 for mfg.Report #9681834-2014-00298 to provide the date.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

This report is being submitted as follow up # 2 to correct the date of event in that was reported in the initial report as (b)(6) 2014.The date of event for this complaint is (b)(6) 2014.

• Brand Name: CAPIOX RX05 OXYGENATOR
• Type of Device: 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: 4316740
• MDR Text Key: 5208214
• Report Number: 9681834-2014-00298
• 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,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: CX-RX25RE
• Device Lot Number: 140703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/05/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2014
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• 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