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

Catalog Number CX-XRX21501

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineering.Pma/510(k)- k130520.The actual sample was received for evaluation.Visual inspection revealed no breakage or other external anomalies.Air was blown into the gas channel of the actual sample.A pinkish liquid was observed to flow out.The liquid was collected, centrifuged, and some deposit was observed.The deposit was checked with a laser microscope and found to be a type of bacteria.The actual sample, after having been rinsed and dried, was filled with colored physiological saline solution, and then tested for leakage by air of 2kgf/cm2 being applied.No leak was observed.From this, it was presumed that there were no anomalies that could lead to the leak such as a cut in the fiber.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Performance test results of the fiber lot used in the involved product code/lot product was confirmed to meet the factory's control criteria.Ifu states: do not use this product for a period in excess of six hours.Excessive use for over six hours may lead to plasma leak and thrombi formation, which may compromise the gas exchange performance.Do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.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.As a cause of the plasma leak, it was likely that due to a change in the blood properties, a surface-active substance may occur in blood and disrupt the balance, which is maintained in the micropores of the fiber, between the surface tension of blood and the gas pressure.Such condition may lead to plasma leak.In particular, for the patients with renal / hepatic failure, plasma leak tends to occur in a shorter time.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported the capiox custom pack was used during the procedure.During operation, after three or four hours, a suspected plasma leak occurred.During gas flush, a significant amount of suspected plasma leak was observed.When it occurred, there was also a decrease in oxygenation performance, which was coped with increasing fio2.The patient was not harmed.The procedure outcome was not reported.

• 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: 12437734
• MDR Text Key: 270306483
• Report Number: 9681834-2021-00151
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: CX-XRX21501
• Device Lot Number: 201221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2020
• 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