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

Catalog Number CX-XRX00660

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/19/2020

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 revealed no break, or no other obvious anomaly that could lead to the reported poor gas transfer performance.The gas channel was blown with air.As a result, liquid was flown out from the gas outlet port side.The liquid was tested with protein test paper ("uriace"), and the presence of protein was confirmed.From this, it is likely that the plasma leak occurred due to hydro-philization of the fiber, however, it was not determined when (during use or during return shipment to the factory) the hydro-philization of the fiber occurred.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, no anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications.Blood conditions: hb:12g/dl, temp.: 37°c., ph:7.4, svo2:65%, pvco2: 45mmhg.Circulation conditions: blood flow rate: 6l/min and 4l/min, v/q=1, fio2=100%.O2 transfer volume: @6l/min= 379 ml/min.@4l/min= 272 ml/min.Co2 removal volume: @6l/min= 299 ml/min.@4l/min= 221 ml/min.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 involved in this complaint was not available for review.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 paco2, increase total gas flow.To increase paco2, decrease total gas flow.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.It is likely that co2 could not be sufficiently removed due to the circulation condition (blood temperature, v/q ratio, etc.), or it is possible that the pco2 in the suctioned blood or in the blood flowing into the oxygenator had been increased due to the co2 gas blown in the surgical field.From the state of the actual sample, however, the definite cause of the poor gas transfer performance could not be determined.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 the involved capiox custom pack was used during the a taa case.After five hours of circulation and de-clamping, co2 removal performance dropped.Gas flow at 10l/min using gas blender could not decrease co2 to less than 80.Another oxygenator was added.Reported no problem with o2 value.The procedure outcome was not reported.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: theresa mussaw ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 10821696
• MDR Text Key: 217656272
• Report Number: 9681834-2020-00229
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: CX-XRX00660
• Device Lot Number: 200617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2020
• 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