MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number ZZ*FX25WA

Device Problem Infusion or Flow Problem (2964)

Patient Problem Blood Loss (2597)

Event Date 07/04/2017

Event Type  Injury  

Manufacturer Narrative

Udi number for this product code is not required.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies which would relate to a gas leak or insufficient gas transfer performance.The actual sample, after having been rinsed and dried was tested for its gas transfer performance in accordance to the factory's shipping inspection protocol.Bovine blood was circulated in the oxygenator module under certain conditions.No anomalies were revealed in the gas transfer performance of the actual sample with the obtained values meeting manufacturing specifications.The colors of the venous and arterial blood were observed during the testing.Arterial blood was found to have become bright red.A review of the photos show the state of the actual sample upon being received.Tcvs found clot formation inside the oxygenator module.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other complaints of this nature with the product code/lot number combination.There is no evidence this event was related to a device defect of malfunction.The investigation result verified the actual sample was the normal product with no issue in the gas transfer performance.While the exact cause of the reported event cannot be definitively determined based on the available information and photos that show the clot formation in the actual sample, it is assumable the clots formed inside the actual sample hindered the gases from being transferred sufficiently.The device labeling does address the potential for such an event in the instruction-for-use (ifu) with statements such as the following: measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.A phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patient's metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism.Do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported insufficient gas exchange in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: during cardiopulmonary bypass it was reported the arterial blood was dark; two minutes into the surgery the perfusionist decided to change out the device; there was a two minute delay in the procedure; 240 ml of blood loss was reported; and the procedure was completed successfully.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6763264
• MDR Text Key: 81704014
• Report Number: 9681834-2017-00165
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: ZZ*FX25WA
• Device Lot Number: 161118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• 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 Outcome(s): Other