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

Catalog Number CX*FX05RW

Device Problem Insufficient Heating (1287)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Weight - (b)(6) kg.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k) no: k130280.The actual device was received for evaluation.Visual inspection upon receipt found that the housing component on the gas-out side almost came off.This damage was not reported in the reported event and it is most likely that it occurred on the actual sample during transportation back.In the inside of the gas-in side, some leaked blood-like discolored substance was found.The actual sample was rinsed, built into a circuit with tubes and tested for the heat exchange performance in accordance with the shipping inspection test method.The test result revealed that the actual sample's heat exchange performance was out of the specifications.During the test a leak was noted from the blood phase.The water phase was confirmed to have no leak.The risk of a leak of water from the constant-temperature bath into the blood phase was eliminated.The actual sample was rinsed again and subjected to x-ray fluoroscopic inspection.It was revealed that one side of the bellows had not been properly caulked.It was also found that the accordion-like part of the bellows was not as wide as the one of the normal product.The actual sample was disassembled, and the bellows was closely inspected.It was found that its water port side did not have any impression of caulk processing.Review of the movie taken during the production of the involved lot number found that one uncaulked unit out of 356 units was flowed to the next production process.It is likely that due to not-thorough line clearance during the production of the involved lot # allowed the actual defective sample to be flowed to the next production process as an acceptable product.A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no findings.The investigation findings revealed that the actual sample did not meet the specifications for its heat exchange performance.It is likely that due to the bellows not having been properly caulked, its accordion-like part was made to become smaller than normal by centrifugal force applied to the product during the urethane potting process.Deformation of the accordion-like part obstructed proper water flow, leading to the poor heat exchange performance.In addition, due to the bellows not having been properly caulked, a leak channel was generated in the blood phase by the shock load the actual sample was subjected to during the transportation.Based on the complaint report, it is likely that there was no leak during the circulation.The cause of the uncaulked bellows having been flowed to the next production process was determined to be inadequate line clearance.Terumo has determined the reported event to be manufacturing related and is being further investigated.(b)(4).

Event Description

The user facility reported that the involved capiox device was used during the procedure.The perfusionist could not rewarm the blood of the patient during cpb.She confirmed the heater and cooler was normal.The oxygenator was not changed during the surgery, and the operation was finished.

• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 4103927866
• MDR Report Key: 8874060
• MDR Text Key: 160048374
• Report Number: 9681834-2019-00141
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071572
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 190124C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2019
• 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 Age: 1 YR
• Patient Weight: 6