MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15 W/ 3L RESERVIOR (RT. PORT); BLOOD GAS OXYGENATOR

Catalog Number CX*RX15RE30

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

The user facility reported breakage on the yellow caps of the rx15 device.Follow up communication with the user facility reported the following information: (1) the perfusionist removed the oxygenator from the box; (2) it was noticed that the yellow luer lock caps to the arterial sample blood localized over the reservoir were fractured; and (3) the procedure was completed successfully.

Manufacturer Narrative

Conclusion code - (68) other; device sustained shock during shipping and /or handling.The actual device was returned to the manufacturing facility and evaluation.Visual inspection upon receipt confirmed the customer's complaint.All of the yellow-caped side ports on the blue, red and yellow stop cocks had been fractured.Magnifying inspection of the fracture cross-sections on the sampling system found all the ports had been fractured at their bottoms, with the surfaces presenting the smooth state.Magnifying inspection of the fractured ports found all of them had the trace implying that the yellow caps had come into contact with an object.The fractured ports were fixed back to the sampling line system in place to see the location of the trace on the yellow caps.This revealed that the object had come into contact with the yellow caps from the above.Electron microscopic inspection of the fracture cross-sections on the sampling system found the whole surfaces were in the smooth state.A radial pattern was found to have been generated on the each fracture cross section, starting at one point located on the upper part of the fracture.This point the pattern started can be regarded as the point the generation of the fracture started.Subsequently, each starting point was examined at higher resolution.No embedded particle or no entrainment of air bubbles was confirmed.Visual inspection of the original unit box returned along with the actual sample found that one of the cushion materials had been deformed into a crushed shape.The framing cushion materials were removed for further inspection of the outer box.No significant damage was noted on it.From these findings, the deformity found on one of the cushion materials is likely to have been generated during the transportation back to japan.Reproductive testing was conducted.A current product sample was exposed to an instantaneous shock force on the yellow-caped ports on the sampling system from the above direction.The ports got fractured.Electron microscopic inspection of the fracture cross-sections revealed the state of their surfaces were very similar to that observed on the actual sample.A review of the dhr and the shipping inspection record of the involved product/lot# combination confirmed there were not any indications of production related problems or any discrepancies in the inspection result.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 the exact cause cannot be determined based on the available information, the appearance of the involved sample is most consistent with the ports being subjected to a shock force during being unpacked by being hit against an object.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "do not use if the package and/or device is damaged or if caps are not in place".All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).

• Brand Name: CAPIOX RX15 W/ 3L RESERVIOR (RT. PORT)
• 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: 4738909
• MDR Text Key: 16460523
• Report Number: 9681834-2015-00078
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051997
• 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: 04/10/2015,04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: CX*RX15RE30
• Device Lot Number: 140616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/26/2015
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2015
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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