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

Catalog Number	CX*HC11S
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was received for evaluation.A review of the image of the actual sample during the case revealed that the actual sample had been installed upside down.The filtrate was seen light red.Visual inspection of the actual sample revealed no obvious anomaly including a break in the appearance.The actual sample was rinsed, subjected to another closer visual inspection, and then confirmed not to have any anomaly, such as a break, which could have led to a blood leak.The actual sample was built into a circuit with tubes.With a help of a roller pump, bovine blood (ht:25%, 37oc) was let to flow through the circuit.As a result, no blood leaked to the filtrate side.The actual sample was tested for its ultrafiltration performance.The obtained result was confirmed to meet the factory's specifications.The filtrate was found transparent.After the above tests, the pressure loss was determined during the circulation at the flow rate of 500ml/min.And tmp of 400mmhg.The obtained result was confirmed to meet the manufacturer specifications.Bovine blood, which was intentionally changed to be hemolytic, was let to flow in the actual sample with roller pump.The filtrate was found to be transparent red liquid.After having been rinsed, did not have any anomaly in its performance, with the ultrafiltration performance and pressure drop meeting the specifications.The filtrate from the actual sample during the above investigation using normal bovine blood was found transparent with no indication of blood leak.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Ifu states: set the haemoconcentrator so that blood flows from bottom to top.Bubbles in the system may cause clotting and blood damage.A few minutes may be necessary until the filtrate phase and filtrate line are filled at the initiation of ultrafiltration.The maximum transmembrane pressure (tmp) is 500mmhg(67kpa).Do not exceed 500mmhg(67kpa).Stop using the haemoconcentrator if blood leakage, clotting or any other problem is observed.Replace it with a new one.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 the normal product.It is likely that the following factors may have caused hemolysis and the hemolytic blood may have flowed into the filtrate side; because blood priming was performed.When blood is used in priming, hemolysis attributable to the haemoconcentrator may be improved when the fibers become wet; because the haemoconcentrator was installed upside down, the filtrate did not accumulate in the filtrate phase, which caused blood to be excessively concentrated.If the haemoconcentrator was re-set into the proper position, filtrate may have accumulated in the filtrate phase and the hemolysis attributable to the haemoconcentrator may have been improved.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that during use of the capiox hemoconcentrator during the cpb case, the perfusionist found the filtrate was red, the actual sample was changed out with another hc11s, and the situation became normal.There was no harm to the patient.The procedure outcome was not reported.

• 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: 9699307
• Report Number: 9681834-2020-00010
• Device Sequence Number: 1877845
• Product Code: KDI
• UDI-Device Identifier: 04987350738394
• UDI-Public: 04987350738394
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 07/31/2022
• Device Catalogue Number: CX*HC11S
• Device Lot Number: 190828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 45