MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF; BLOOD GAS OXYGENATOR

Catalog Number CX-XRY17602

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2015

Event Type  malfunction  

Event Description

The user facility reported insufficient gas exchange in the capiox device during a procedure.Follow up communication with the user facility reported the following information: the actual sample was used on the patient who was put on the pcps circulation; around 2 hours after the initiation of the circulation, pao2 was noted to have decreased; fio2 was increased to 100% and the gas flow rate up to 12l/min.; and the patient was weaned off bypass.

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection of the actual sample upon receipt found no obvious abnormalities which could have caused or contributed to the reported insufficient gas transfer performance.The actual device was sterilized with glutaraldehyde solution and the housing component was removed for further inspection of the inside of the oxygenator module.Visual inspection did not find any thrombus formation either on the filter or the inside of the fiber layer.After removing the fiber layer, the heat exchanger module was inspected under magnification.There was no formation of thrombus on the outer cylinder of the heat exchanger module.The fiber that had been removed from the oxygenator module was inspected under magnification, and it was confirmed there was no presence of thrombus.A review of the device history record of the involved product/lot# combination confirmed there were no indications of production related anomalies.A search of the complaint file found no other report with the involved product/lot# combination.The provided perfusion record was reviewed.The patient was (b)(6).Pao2 was always kept above 300mmhg all the way through the case.Although an exact cause for the reported issue cannot be determined based on the available information and device evaluation, there is no evidence that this event was related to a device defect or malfunction.The actual sample did not reveal any anomalies that would have contributed to the reported issue.In addition, the perfusion record showed no indications of a decrease in the pao2.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: measure blood gases and make necessary adjustments.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2 and to increase pao2, increase fio2.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF
• 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: kathleen little ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4840410
• MDR Text Key: 21552446
• Report Number: 9681834-2015-00106
• 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: 05/19/2015,06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: CX-XRY17602
• Device Lot Number: 150123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/19/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2015
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• 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
• Patient Age: 65 YR
• Patient Weight: 65