MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	1CX*FX15E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.- results = 3244 is based on the returned photograph of the actual device; 213 is based on the retention sample evaluated.D4: udi - not yet required for this product code/lot number combinaiton, however the di portion was provided.The actual device has not been returned to the manufacturing facility.However, a photograph of the involved device was returned for evaluation.Therefore, the investigation was based upon evaluation of user facility information, a photograph of the involved device and a retention sample of the involved product code/lot# combination.The returned photograph of the actual device revealed the adhesion of clots inside the oxygenator module and on the rib set inside the venous filter.Visual inspection of the retention sample revealed no defects.The retention sample was built into a circuit with tubes and bovine blood was circulated through it.The pressure drop was determined at each specified flow rate.The obtained values were verified to meet manufacturing specification.No obstruction was observed inside the oxygenator module.Bovine blood was then circulated for 6 hours and no obstruction was observed inside the oxygenator module.The bovine blood was rinsed out of the retention sample and was subjected to another visual inspection.No obstruction was observed inside the oxygenator module.The actual device has not been returned to the manufacturing facility for evaluation and the investigation is still on going.For this reason, evaluation code 11 was used in the conclusions section of h6.A follow up report will be submitted within 30 days of this report being sent.A review of the device history record and product release decision control sheet of the involved product/lot# combinations was conducted with no relevant findings.A search of the complaint file found no report with the presumed product code/lot# combinations.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.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.H3 other text : device not yet received.
Event or Problem Description
The user facility reported the oxygenator flow suddenly started dropping to where the customer could not get adequate flow.Follow up communication with the user facility confirmed the following information: the customer went on pump today and flow was fine; all blood gasses were fine and suddenly flow started dropping and the customer could not get adequate flow; flow dropped down to 2 lpm however all blood gas levels remained the same and in good parameters; the customer changed out the fx15r in 2-3 minutes with no major delay and the patient never lost oxygenation; svo2 got down to 66 but once changed out and back on the pump everything worked well as usual; the surgery was completed successfully; and there was no impact to the patient.
Additional Manufacturer Narrative
This report is being submitted to provide the device return date in device available for evaluation? & to provide the returned sample evaluation results.The actual device was returned to the manufacturing facility for evaluation.Visual inspection revealed that some clots had been formed inside the oxygenator module.The actual sample was rinsed and dried and then subjected to another visual inspection and revealed no defects.The actual sample was built into a circuit with tubes.Bovine blood was circulated in the circuit and the pressure drop was determined at each flow rate.The obtained values were confirmed to meet manufacturer specifications and no obstruction that could lead to an increase in the pressure was found.Bovine blood was circulated in the circuit for 6 hours.No obstruction was observed that could lead to an increase in the pressure.The actual sample was then rinsed out.Subsequent visual inspection confirmed no clot formation.There is no evidence that this event was related to a device defect or malfunction and the exact cause of the reported event cannot be definitively determined based on the investigation results.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX FX15 HOLLOW FIBER OXYGENATOR AF
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6108930
• Report Number: 9681834-2016-00254
• Device Sequence Number: 19001015
• Product Code: DTZ
• UDI-Device Identifier: 04987350701183
• UDI-Public: 04987350701183
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

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: 05/31/2019
• Device Catalogue Number: 1CX*FX15E
• Device Lot Number: 160609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other