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

Catalog Number	CX*FX15E
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted patient height: 5'7" the actual sample was not returned to the manufacturing facility for evaluation.A factory-retained sample from the involved product code/lot number combination was evaluated.Visual inspection revealed there were no obvious anomalies, such as a break, in the appearance.The retention sample was built into a circuit with tubes.Bovine blood was circulated in the circuit, while the pressure drop was determined.The obtained values were confirmed to meet manufacturer specifications.It was verified that the flow rate was able to reach 5l/min., which is the maximum flow rate for fx15.The sample was then flushed with water.No clot formation was found inside the retention sample.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 findings.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.Based on the provided user facility information, it is likely that some clots formed inside the actual sample; obstructed the oxygenator module, resulting in the reported event.However, with no return of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.
Event or Problem Description
The user facility reported an oxygenator failure with the involved capiox fx15 device during cardiopulmonary bypass.The device was changed out for a capiox fx25 device.There was no blood loss or patient injury, and the patient did ok.The case was to remove right atrial mass.Index flow: 4.7l/min.Pre-checked cannula flow: ok.Activated clotting time (act): 413sec.Platelets (plt): 365k, hematopoietic cell transplantation (hct): 47, body surface area (bsa): 1.94, 2,4.Gave 15k heparin more plus 10k heparin in cpb.Went on bypass, flow was up to 4l/min, rpm of 2300; a resistance of 185mmhg; stayed warm.Four min into it, the flow was noticed to be getting low; to around 3.2.Ran the act: 970sec.Rpm was increased from 2300 to 3500, (max), flow of 3l/min; a resistance of 135.Surgeon was asked if there was a kink or any issue with the cannula, negative for either.The oxygenator side was checked, there was no kink.The bypass line was opened, there was no resistance.Calculated possible protein buildup or excess platelet coating due to sirs.They decided to change out the oxygenator rather than waiting it out.Came off bypass at 1436; changed out the oxy; took five min; went on bypass; air free, at 1441.Was able to flow to 4.5 l/min with a resistance of 220mmhg, rpm 2230.There was no issue after, through the end of the case, and the procedure was completed successfully.
Additional Manufacturer Narrative
The actual sample was not returned for evaluation.A factory-retained sample from the involved product code/lot number combination was evaluated as follows.Visual inspection revealed there were no anomalies, such as a break, in the appearance.The retention sample was built into a circuit with tubes.Bovine blood (@hct35% and temp.37oc) was circulated in the circuit, while the pressure drop was determined.The obtained values were confirmed to meet manufacturer specifications.It was verified that the flow rate was able to reach 5l/min., which is the maximum flow rate for fx15.The retention sample was flushed with water.No clot formation was found inside the retention sample.Ifu states: 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.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the retention sample was of the normal product.Based on the investigation results and user facility information, it is likely that some clots formed inside the actual sample and obstructed the oxygenator module.However, with no return of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
Additional information was received on january 23, 2019.The perfusion record was received and reviewed and revealed: at 14:24, the bypass was initiated at the flow rate of 3.5l/min.There was a comment; x14:30 saw drop in flow and increase in rpm.Rpm at 3500 flow 2.5l/min.From 14:24 to 14:27, in spite of the increased rpm from 2800rpm to 3500rpm, the flow rate was dropped from 3.5l/min to 2.8l/min.The pressure was stable.

• Brand Name: CAPIOX FX 15
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8277413
• Report Number: 9681834-2019-00003
• Device Sequence Number: 1500928
• Product Code: DTZ
• UDI-Device Identifier: 04987350701183
• UDI-Public: 04987350701183
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CX*FX15E
• Device Lot Number: 180322
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10K HEPARIN; 15K HEPARIN; 10K HEPARIN; 15K HEPARIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 82