MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF; OXYGENTOR

Catalog Number ZZ*FX25RW

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

The actual device has not been received by the manufacturing facility for evaluation.A follow up report will be submitted within 30 days from the date that this report was sent.A review of the device history record and product release decision control sheet of the involved product/ lot # combination confirmed there were no indications of production related problems or discrepancies in the test/inspection results.A search of the complaint file did not find any other report with the involved product/lot # combination.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.Actual device not returned.

Event Description

The user facility reported clogging in the capiox fx25 device.Follow up communication with the user facility reported the following information: central or 25: premature hlm started with circulatory problems; heparinization was adequate; a transfusion of 5000ml of blood was necessary to stabilization the patient; about 10 minutes after starting hlm the passage from the venous side to the centrifugal pump by the venous reservoir was clogging; the hlm was stopped for a short period of time to replace the oxygenator; the patient had own heart rhythm during this time and blood pressure was low; he perfusionist proceeded and completed the procedure without further incidents; the volume of the blood loss was equivalent to the volume filled in the reservoir; the patient expired the following day, (b)(6) 2015; and it was reported by the cardiotechnician that the death of the patient definitely was not related to the oxygenator.

Manufacturer Narrative

This report is being submitted as follow up no.1 for mfg.Report no.9681834-2015-00263 to provide additional information received.As of (b)(6) 2016 the actual device used has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted within 30 days from the date that this report was sent.(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

This report is being submitted as follow up no.1 for mfg.Report no.9681834-2015-00263 to provide additional information received.It was confirmed that the transfused blood was 5000ml and the volume of the blood loss was 500ml.

Manufacturer Narrative

This report is being submitted as follow up no.2 for mfr.Report no.9681834-2015-00263 to provide the returned sample evaluation results.The actual sample was returned to the manufacturing facility for evaluation.Each component of the actual sample, after having been rinsed and dried, was visually inspected and no anomalies were revealed.The venous reservoir that was changed out during the involved procedure was tested for blockage and confirmed to inflate.The oxygenator module was built into a circuit with the factory-reserve tubes, in which bovine blood was circulated while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet manufacturing specifications.The bovine blood was circulated in the circuit for 6 hours.No plugging occurred in the oxygenator module.The blood was removed from the circuit for further inspection of the oxygenator module.There was no clot formation inside of the oxygenator module.Each component of the actual sample, including the oxygenator module, soft and hard shell venous reservoirs and tubes were built into a circuit and filled with saline solution.The competitor's centrifugal pump originally connected to the actual sample was changed to a terumo centrifugal pump.With the terumo centrifugal pump set to 2000rpm, and with a blood tank simulating the patient placed higher than the venous reservoir by 70cm, saline solution was circulated under random circulation conditions in the circuit.No blocking occurred in the venous reservoir.The investigation result confirmed no anomalies or plugging on the sample.Based on available information the cause of this complaint cannot be determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow up no.2 for mfr.Report no.9681834-2015-00263 to provide the returned sample evaluation results.

• Brand Name: CAPIOX FX25 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: 5349984
• MDR Text Key: 35209366
• Report Number: 9681834-2015-00263
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2015,01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: ZZ*FX25RW
• Device Lot Number: 150521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/30/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2015
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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
• Patient Age: 73 YR