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

Catalog Number 1ZZ*FX15EA

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

There is no applicable udi no.For this product.This is a bulk product.The actual device has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.A review of the device history records and product release decision control sheet of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Device not returned to manufacturer.

Event Description

The user facility reported a clot in the capiox fx15 device.Follow up communication with the user facility reported the following information: (1) the oxygenator clotted during cardiopulmonary bypass; (2) the product was not changed out; (3) the surgery was completed successfully; and (4) there was no impact to the patient.Additional information was reported from the perfusionist on (b)(6) 2016: the filter did its job.The filter became obstructed and flow from the centrifugal pump decreased.The patient was in full flamed inflammatory response, had what appeared to be white clot in the filter.The patient had endocarditis, was a fresh mi and had a carotid endarterectomy prior to cpb.Albumin was added to the pump prime.The restriction to flow occurred as soon as cpb was initiated.They drift to 34 degrees and perfusionist warmed back up to 37 degrees thinking that the patient may have had cold agglutinins but the cardioplegia was cold and didn't clump.He then cooled back down to 34 degrees.The oxygenator was not changed out.The pump flow was low (~2+ lpm) for about 30-45 minutes and then all of a sudden started increasing a couple hundred milliliters per minute about every 3-4 minutes and when they reached their targeted calculated flow he backed off on the rpms to maintain that flow.The oxygenator gas exchange performance was optimal, no problems with gas exchange.Their initial target act is 600 seconds and then they let it drift down to 480 but in this case the acts hung around the high 500 seconds range throughout the procedure.The patient was acidotic pre-op, pre-cpb and during cpb.They prime with 1100-1200 ml depending on what drugs they add for a particular case and rap off 500-500 mls.The hct pre-cpb was 36% and during cpb it was 34%.The patient did not have any blood transfusions.When they rinsed the oxygenator post-cpb they noted what appeared to look like clumped platelets.The following information was obtained from the involved perfusionist through a phone conversation.This patient was a 1.9 m2 male recently transferred from another hospital who was experiencing an inflammatory crisis on many levels.Severe pericarditis, carotid disease, extreme metabolic acidosis upon entry into the or.The patient had received a foley catheter from another institution that had to be changed out due to a bloody pus discharge that was occurring.The procedure was a cabgx4.The fx-15 was appropriately chosen for the patient.Initial act after heparin appears to be 428 seconds with elevation to 750 seconds.Heparin concentration was 4.1.Immediately after going on bypass, it was noted that significant elevation of the rpm was necessary to achieve forward flow.At 1030, the flow was 2.3 l/m at max rpm of 3600.Because blood gases weren't being adversely affected, at 500 po2 , co2 42mm/ hg at 80% and 2.7 l/m gas flow, venous sats were at 74%, the perfusionist made the decision to continue on with the procedure without changing anything.Approximately 25 minutes into the procedure the relationship between rpm and flow improved over time to where rpm and flow returned to normal level, achieving 5.6 l/m at the end of bypass.The case was finished without incident and as of thursday afternoon, the patient was doing "ok" considering the condition in which the patient came to surgery.Temperature change didn't seem to have any effect on the hpe event according to the perfusionist.

Manufacturer Narrative

This report is being submitted as follow up # 1 to provide the retention sample evaluation results and to correct the product code that was initially reported in.The correct product code is 1zz*fx15ea.The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based upon evaluation of user facility information and a retention sample of the involved product code/lot# combination.Visual inspection revealed no defects.Bovine blood was circulated through the device while the pressure drop was determined and confirmed to meet manufacturing specification.Bovine blood was then circulated for six hours and no obstruction occurred.The investigation results verified that the retention sample was the normal product.Based on the complaint information that the restriction of flow occurred as soon as cpb was initiated, it is unlikely that the actual sample had an obstruction to the lead the blood to form clots.With no return of the actual sample, the cause cannot be definitely determined.However, there is no indication that the reported event was related to a device defect or malfunction.The indications which may relate to this complaint can be found in the ifu of this product as follows: "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." all available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF
• 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5873145
• MDR Text Key: 52171680
• Report Number: 9681834-2016-00197
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1ZZ*FX15EA
• Device Lot Number: 151211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• 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