MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX CUSTOM PACK; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-XRZ00901

Device Problem Increase in Pressure (1491)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual sample was received for evaluation.Visual inspection revealed no anomaly including a breakage in the appearance.The actual sample was built into a circuit with tube, and then normal saline was circulated at each flow rate while the pressure drop was determined.Compared to current product sample, no marked difference was observed in the obtained values.The actual oxygenation module was fixed by being filled with glutaraldehyde-containing normal saline, and then the housing and the filter were removed.Visual inspection of both the outer and inner sides of the filter found no formation of blood clots that could lead to the pressure rise.The oxygenation module was visually inspected.Formation of blood clots that could lead to the pressure rise was not confirmed.No anomaly was noted in the state of fiber winding.The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections.No anomaly such as an obstruction was observed in the flow path.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Pump record showed that the pressure drop of oxygenator increased at the same time when ecc started at 12:43.From this it was presumed that a clogging occurred in the oxygenator leading to the increasing pressure drop.At 12:58, the pressure drop of oxygenator increased up to 240 mmhg.After that, it decreased gradually whereas the flow rate was constant.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.It is likely that the cause of this issue was a change in blood properties that could lead to the generation of blood-derived embolic substances and accompanying 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.(b)(4) 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 custom pack was used during the procedure.After the start of the cardiopulmonary bypass, the pressure of the oxygenator increased.After watching the situation for a while, the pressure value settled down to the normal value, so the oxygenator in question was not replaced and used as it was, and the procedure was completed.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX CUSTOM PACK
• 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; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 11854043
• MDR Text Key: 261947782
• Report Number: 9681834-2021-00078
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: CX-XRZ00901
• Device Lot Number: 201022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• 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