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

Catalog Number CX-FX15RW30V

Device Problem Crack (1135)

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

Event Date 06/14/2021

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 engineer.Pma/510(k): k130520.The actual sample was received for evaluation.Visual inspection revealed cracks at the base of a blade of the adapter and at the screw part.Magnifying inspection of the actual sample found bloodstain in the cracks, which inferred that blood leaked through the cracks.The cracked parts were inspected with polarized light strain viewer (the flow of resin is visible by iridescent patterns (interference colors) when molded resin products are seen with polarized light strain viewer).Compared with a current product, no unusual resin flaw or other anomalies were observed in the actual sample.Simulation testing was performed.An attempt was made to forcibly fit an adapter sample into the blood outlet port of a factory-retained oxygenator with pliers.The adapter ran idle but did not crack.Next, an adapter sample was crushed with a vise until the outer diameter was reduced to about one-third.The adapter was deformed but no cracks occurred.Assuming cracks due to an effect of chemicals, after applying a chemical to a blood outlet port, an adapter sample was tightened and left for a certain time.As a result, cracks occurred at the same positions as the actual product.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 use solvents such as alcohol, ether, acetone, etc.These solvents may cause damage if used in or on the device.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It was likely that the chemical cracks may have occurred from a point that was exposed to the stress caused by the adapter being tightened to the blood outlet port while some kind of chemical was attached to the port.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 device was used during the elective procedure on a child.During surgery, blood was found to be dripping from the 3/16" adapter attached to the oxygenator outlet port.After the surgery, a crack was found in the adapter.Estimated blood loss was 100 ml by visual measurement.The procedure was completed successfully.The patient was not harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• 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: 12157476
• MDR Text Key: 265199250
• Report Number: 9681834-2021-00117
• 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: 07/13/2021

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: 10/31/2023
• Device Catalogue Number: CX-FX15RW30V
• Device Lot Number: 201113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• 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 Weight: 5