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

Catalog Number 1CX*FX15W

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

The actual device has not been returned to the manufacturing facility for evaluation.A follow up will be sent within 30 days of this report being sent.A review of the device history record and the product released decision control sheet of the involved product/lot# combination was conducted with no relevant findings.A review of the complaint history files confirmed that the involved product/lot# combination has not been reported previously.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

Event Description

The user facility reported thrombus in the capiox cx*fx15w device during cardiopulmonary bypass.Follow up communication with the user facility reported the following information: cardiopulmonary bypass was initiated @ 9:24am; the perfusionist noticed a dark area on the fiber bundle which later became lighter in color or white in color on the fx15 device; the oxygenator was changed out @ 10:43 am; there was approximately a two minute delay in the procedure for the change out of the entire circuit; the perfusion team strained approximately 500cc of blood through a coffee filter and sent it to the hospital pathology for analysis of the white globular substance; pathology determined it was not fat but could not determine the exact composition; the surgery was completed successfully; the patient condition is unknown.See mdr # 9681834-2015-00230 regarding the second device used that stated to have the same phenom on the new circuit.

Manufacturer Narrative

As stated, this report is being submitted as follow-up no.1 for mfg.Report no.9681834-2015-00229 to provide the returned sample evaluation results.Results/conclusions - is based upon evaluation of user facility information and the returned photo; is based upon evaluation of the returned sample.The actual device and a photo were returned to the manufacturing facility for evaluation.Visual inspection upon receipt revealed no defects.The actual sample was rinsed and dried and subjected to another visual inspection.No anomalies or defects were revealed.The actual sample was built into a circuit with tubes and bovine blood was circulated through it at each flow rate, while the pressure drop was determined and confirmed to meet manufacturing specifications.The actual sample was disassembled and the state of the x-coat applied to the inside surface of the housing confirmed no anomalies or defects.The photo of the actual device under actual use revealed the presence of white thrombus formed inside the oxygenator module.The perfusion record was reviewed as follows: @ 9:24 cpb was initiated with the first oxygenator; @ 9:49 paco2=37.5mmhg and pao2=310mmhg.These values indicate that the gases were being transferred sufficiently; @10:43 the oxygenator was changed out to the second one (the one involved in this complaint); @11:08 paco2=39mmhg and pao2=440mmhg.These values indicate that the gases were being transferred sufficiently; @11:54 cpb with the second oxygenator discontinued.The cause for the reported event cannot be definitively determined based upon the available information since the investigation results verified that the actual sample was the normal product.There are many complex clinical variables that may have affected the reportedly observed conditions during the procedure, however there is no evidence that the reported event was related to a product malfunction or defect.The device labeling (ifu) does address instructions with statements such as the following: 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.

Event Description

This report is being submitted as follow-up no.1 for mfg.Report no.9681834-2015-00229 to provide the returned sample evaluation results.

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF
• Type of Device: OXYGENTOR
• 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: 5165378
• MDR Text Key: 28827320
• Report Number: 9681834-2015-00229
• 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,Followup
• Report Date: 10/01/2015,10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 1CX*FX15W
• Device Lot Number: 150415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/01/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2015
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• 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 Outcome(s): Other