MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX05RE

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- (b)(6).Pma/510(k)- k130280.The actual sample was received for evaluation.Visual inspection revealed no breakage in the visible range.The actual sample was rinsed, dried, and built into a circuit with tube.Bovine blood (hct35% and temp.37°c) was circulated at 1.5l/min in the circuit, while the pressure drop was determined.The obtained values were confirmed to meet the factory's specifications.No blockage was confirmed.The blood that had remained in the circuit was collected, fixed with glutaraldehyde-containing physiological saline solution, and then dried for electron microscopic inspection.Deformed red blood cells (echinocytes) were observed.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.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.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.Based upon the description of the event that the priming was performed while removing water, and on the investigation result that the echinocytes was observed in the blood collected from the actual sample; it is likely that the blood viscosity increased due to increasing hct, which resulted in the oxygenator pressure rise; the blood fluidity decreased due to red blood cells having been deformed for some reason, which resulted in the oxygenator pressure rise.However, 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.(b)(4).

Event Description

The user facility reported that the capiox device was used during the procedure.Priming was performed with water first, and then blood was added while water was removed.The oxygenator pressure increased to 300.They felt anomaly and re-connected the pressure line to measure again, however found it increased around 400.The oxygenator was exchanged for a new one.Circuit and shunt sensor were changed out also.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11654664
• MDR Text Key: 261208356
• Report Number: 9681834-2021-00057
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: CX-FX05RE
• Device Lot Number: 201015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other