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

Catalog Number CX*FX05RW

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130280.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The actual sample in disassembled condition was received for evaluation and currently under investigation.The provided image showed that the venous inlet drop tube inside the venous filter was kinked.Visual inspection of the actual sample as revealed that one of the venous inlet drop tubes seemed to have been crushed at the root.A part of the defoamer was found to have been pushed inward when seen from the upper side.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the capiox device was used during the procedure.They had ran on bypass with the svc can and just inserted the ivc cannula, were expecting full flows, although could not be achieved.The case was on bypass about 30mins longer than it should have been while the issue was diagnosed.The venous line into the reservoir was bypassed so that we could achieve full flows.The surgery was completed successfully.There was no blood loss.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation.The actual sample was investigated.The lid and the filter had been detached from the reservoir when received.Visual inspection of the actual sample revealed that the venous inlet drop tube had been kinked at the connection with the venous blood inlet port as if it had been squeezed.Visual inspection of the filter part of the actual sample found that a part of the defoamer had been deformed as if it had been compressed inward.Regarding the involved product code/lot#, the monitoring video in the production process was reviewed and no anomaly was observed in the work or operations.As for the kink of the venous inlet drop tube, it was presumed to have occurred when the defoamer and the inner frame of the filter were set to the reservoir in a manner that they were squeezing the connection part between the venous inlet drop tube and the venous inlet port.The tube is inserted by being slid along the defoamer and the inner frame of the filter, therefore, it is most unlikely that the tube was exposed to an external load.If a kink occurred in the venous inlet drop tube when the defoamer and the inner frame of the filter are inserted while one of the venous inlet drop tubes is held, it is most likely that the repulsive force of the tube would return it to its original shape during the subsequent operations.However, in this very rare case, the kinked tubing might have been sterilized without returning to its normal shape, which presumably caused it to retain its kinked shape.As for the inspection process, it is checked that the tips of the tubes are aligned during the subsequent visual inspection; however, in this particular case, the actual sample was missed probably because of no experience with similar problem in the past.

• 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
• MDR Report Key: 12638250
• MDR Text Key: 276598579
• Report Number: 9681834-2021-00181
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 210120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1