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

Model Number 1ZZ*FX05RWA

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation- ccp.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.(b)(4).

Event Description

The user facility reported that the involved capiox device was used during cardiopulmonary bypass.The oxy gas flow fluctuations, electric blender alarm and flow was bouncing.There was no delay, and the product was not changed out, surgery was completed successfully without patient harm from product malfunction and there was no blood loss.They changed out gas filter and 15-20 mins after severely desaturated at 100% only 60 po2 on cdi.They went to o2 tank and still had low sats and dark lines.Switched to oxygen on mast and gave 4-5l/min flow and got off pump and sats returned, red arterial blood again.They were able to wean from cbg and muf without any oxy change.

Manufacturer Narrative

The actual sample was received for evaluation.Visual inspection revealed no break or no other obvious anomaly in it.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance with the factory's inspection protocol.As a result, the obtained values were confirmed to meet the factory's control criteria.No anomaly in the gas transfer performance was observed.[bovine blood conditions] hb:12g/dl, temp.:37°c., ph:7.4, svo2:65%, pvco2: 45mmhg.[circulation conditions] blood flow rate: 2l/min and 1l/min, v/q=1, fio2=100% [o2 transfer volume] @2l/min= 118 ml/min.@1l/min= 67 ml/min [co2 removal volume] @2l/min= 96 ml/min.@1l/min= 60 ml/min.During the gas transfer performance test, the color of blood was checked also.It was confirmed that the blood in the arterial line was brighter than that in the venous line.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: measure blood gases and make necessary adjustments as follows.A.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.B.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.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.The exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 10884305
• MDR Text Key: 241615698
• Report Number: 9681834-2020-00237
• Device Sequence Number: 1
• Product Code: DTZ
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1ZZ*FX05RWA
• Device Catalogue Number: ZZ*FX05RWA
• Device Lot Number: 190821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1