MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HEMOCONCENTRATOR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	CX*HC11L
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history record from the reported product code/lot number combination was conducted with no findings.A search of the complaint file found no previous report of this nature with the involved product /lot# combination.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 the bypass prime volume was normal, saline and suitable anticoagulant kept at hct 25%, by order ultrafiltration flow 150-200 ml/min.After 5 minutes there was hemoconcentrator failure.The actual sample was changed out to a new hemoconcentrator.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Visual inspection revealed no anomalies.Saline solution was let to flow through the actual sample by gravity.The actual sample was found to be clogged.Subsequently saline solution was let to flow through the actual sample with the use of a roller pump.A sticky lump of clots came out of the actual sample.The actual sample was rinsed.Another visual inspection focusing on the state of the fiber, did not find any anomaly, such as a broken or kinked fiber, which would have related to clogging in the fiber.The actual sample was built into a circuit with tubes and bovine blood (37 oc, hct25%) was circulated in it.It was confirmed that an adequate blood flow rate was achieved.The ultrafiltration performance was determined and confirmed to meet the specifications.After above, the pressure loss was determined while bovine blood was circulated in the circuit at the flow rate of 500ml/min.And tmp400mmhg.The obtained value was confirmed to meet the specifications.A review of the device history record of the product code/lot# combination was conducted with no findings.Ifu states: the capiox hemoconcentrator is designed to operate at flow rate within the range of 100 to 500ml/min during ultrafiltration.Do not use blood flow rates outside this range.Less than 100ml/min blood flow may cause blood coagulation in the device.Do not exceed 50% hematocrit at the blood outlet during ultrafiltration.Do not stop blood flow during extracorporeal circulation as it may cause clotting in the system.A blood flow of least 50ml/min is recommended even if ultrafiltration is stopped by clamping the filtrate line.Bubbles in the system may cause clotting and blood damage.There is no evidence that this event was related to a device defect or malfunction.The inspection results verified that the actual sample, after having been rinsed, was the normal product with normal ultrafiltration performance and the normal pressure loss.It is likely that the ultrafiltration performance may have been deteriorated due to the fiber clogged by clots.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX HEMOCONCENTRATOR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7714141
• Report Number: 9681834-2018-00117
• Device Sequence Number: 904412
• Product Code: KDI
• UDI-Device Identifier: 04987350738417
• UDI-Public: 04987350738417
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K973516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CX*HC11L
• Device Lot Number: 180206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1