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

Model Number	1CX*HC05S
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported red tinge on the hemoconcentrator.The effluent was clear when the perfusionist primed with blood.After sitting for an hour, he noticed the red tinge in the hemoconcentrator.The issue was discovered during prime.There was no delay to surgery and the case was completed successfully with no patient harm and no blood loss from product malfunction.The product was not changed out and was used throughout the case.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.The actual sample was obtained after follow up no.1 had confirmation the device was not available; therefore, section d9 has been updated to reflect the device return.The actual sample was received for evaluation.Visual inspection of the actual sample revealed no break or other obvious anomalies in the appearance.The actual sample was built into a circuit with tubes, and then the ultrafiltration performance was determined while bovine blood (hct 25%, 37oc) was circulated at 100ml/min and at 500ml/min.The obtained values were confirmed to be normal and met the factory's specifications.No clogging was observed when blood was flowed in, and no phenomenon in which the filtrate side turns red due to hemolysis during ultrafiltration.Subsequently, the pressure drop was determined when bovine blood (hct 25%, 37oc) was circulated at 500 ml/min.The obtained value was confirmed to be normal and met the factory's specifications.Ifu states: bubbles in the system may cause clotting and blood damage.Stop using the hemoconcentrator if blood leakage, clotting or any other problems is observed.Replace it with a new one.The maximum transmembrane pressure (tmp) is 500 mmhg (67 kpa).Do not exceed 500 mmhg (67 kpa).Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.The exact cause of the reported event cannot be definitively determined based on the available information.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.It was inadvertently initially submitted the device was not available for return date in section d9; although it was initially reported the device was available.However, it has been confirmed the device is not available for evaluation.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Ifu for capiox hemoconcentrator states: bubbles in the system may cause clotting and blood damage.Stop using the hemoconcentrator if blood leakage, clotting or any other problems is observed.Replace it with a new one.The maximum transmembrane pressure (tmp) is 500 mmhg (67 kpa).Do not exceed 500 mmhg (67 kpa).With no device return 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, 418 ; JA 418
• MDR Report Key: 11216101
• Report Number: 9681834-2021-00002
• Device Sequence Number: 17159243
• Product Code: KDI
• UDI-Device Identifier: 04987350738332
• UDI-Public: 04987350738332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2021

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: 03/31/2023
• Device Model Number: 1CX*HC05S
• Device Catalogue Number: CX*HC05S
• Device Lot Number: 200413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/09/2021; 03/08/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 02/17/2021; 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1