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

Catalog Number CX*RX25RE

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

The user facility reported a scar was noted on the tubing of the oxygenator.Follow up communication with the user facility reported the following information: when checking the oxygenator during set up, the tubing at the base of the membrane was seen to have been kinked; upon closer inspection it showed a plastic scar; the oxygenator was returned to its original box; and the original box showed no sign of damage.

Manufacturer Narrative

(b)(4).The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt did not find any anomaly, such as a break, in its appearance conditions.Magnifying inspection of the bonded joint on the sampling line tube to the port found that the tube had a curved shape with a slight separation of the bonding between the tube and the port.The port was confirmed to have the trace indicating that the tube had been once bonded to it.The actual sample was filled with saline solution and pressurized at 2.0 kgf/cm2.No leak occurred from the joint in question.The sampling line tube was cut vertically and the inside and outside diameters and the wall thickness were measured.They were confirmed to meet manufacturing specifications, being comparable to those of the current product sample.Magnifying inspection of the sampling line tube from current product found that it had a curved shape similar to that on the actual sample.A review of the manufacturing record of the involved lot#/product code combination confirmed that there was no indication of production-related problem.A search of the complaint file did not find any other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined, the actual sample inspection demonstrated that it did not have any leak from any joints, including the joint in question.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: 4625713
• MDR Text Key: 5763977
• Report Number: 9681834-2015-00040
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/06/2015,03/24/2015

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: 06/30/2017
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 140729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/05/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2015
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2014
• 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