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

Catalog Number CX-XRX10703

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

The user facility reported a leak at the joint between the purge port on the oxygenator device.Follow up communication with the user facility reported the following information: this was noticed during priming stage; the joint had been tapped gently with forceps for de-bubbling the connection; the operation was completed successfully with a new oxygenator; and there was no patient involvement.

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt confirmed the purge line tube had a partial crack at the edge of the purge port.The purge line was disassembled for further inspection.Magnifying inspection of the crack cross-section on the purge line tube revealed the presence of both a smooth surface and rough surface.The smooth surface indicates that the crack developed rapidly there and the rough surface indicates that the crack developed slowly.Electron microscopic inspection of the crack cross-section revealed the generation of some streaks on the smooth surface, spreading out toward the rough surface.There was the evidence of elongation on the rough surface.The purge line tube was cut vertically on the segment adjacent to the crack for dimensional check.The inside and outside diameters and the wall thickness were determined and verified to meet the specifications, being comparable to those of the current production.The tensile strength of purge line tube was determined by subjecting the purge line tube to a tensile force at a constant rate.It was verified to be comparable that of the current product sample.Simulation testing was conducted.The current product sample was left under the temperature of 4 oc for 12 hours.Subsequently, the purge line tube adjacent to the purge port was exposed to a shock force by being hit with forceps.The purge line tube got cracked.Electron microscopic inspection of the crack cross-section revealed the generation of some streaks on the smooth surface, spreading out toward the rough surface.A review of the manufacturing record and product release decision control sheet of the involved product/lot# combination confirmed there were no production related anomalies.A search of the complaint file found no other similar complaint with the involved product/lot# combination.Based upon the available information, the cause for the reported event cannot be definitively determined.There are many complex clinical variables that may have affected the reportedly observed conditions during the procedure.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

• Brand Name: CAPIOX FX 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: 4342796
• MDR Text Key: 5140491
• Report Number: 9681834-2014-00331
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• 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: 12/02/2014,12/18/2014

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: 08/31/2017
• Device Catalogue Number: CX-XRX10703
• Device Lot Number: 140902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/02/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2014
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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