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

Catalog Number CX-XRX13801

Device Problem Infusion or Flow Problem (2964)

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

Event Date 02/15/2021

Event Type  Injury  

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 upon receipt did not find any 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 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 sides of the filter found no deposit that could lead to the low gas transfer performance.The oxygenation module was visually inspected.No deposit that could lead to the low gas transfer performance was 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 in the flow path was observed.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.The pump record was reviewed, however, no factors that could lead to the low gas transfer performance could be read from the data.Ifu states: start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.Measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.A phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.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 was likely that the gas transfer performance dropped gradually due to some factors.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that while the involved capiox xrx13801 fx25 was being used, oxygenation performance became weakened.They judged that the procedure could not be continued with it and was replaced it with xsa99934, and then no further problem occurred.Observing no anomaly in the oxygenation performance at the start of use, they concluded that the event was not attributable to the fx25.No pressure rise was observed, however, they considered that something clogged with the actual sample leading to the oxygenation performance drop.The procedure was completed successfully.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: 11419881
• MDR Text Key: 238923893
• Report Number: 9681834-2021-00023
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: CX-XRX13801
• Device Lot Number: 200827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• 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 Outcome(s): Other