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

Catalog Number CX-XRX51804

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/18/2021

Event Type  malfunction  

Event Description

The user facility reported that the capiox custom pack was used during a major vessel replacement surgery, about twenty minutes after the start of cooling, the blood gas was measured and the pco2 was found 67.Although the gas flow was increased to cope with it, pco2 remained high even during cerebral perfusion.After rewarming was started, co2 was able to be removed without any problems.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

(b)(6).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 breakage or other anomaly in the appearance.The actual sample was rinsed with normal saline flowed by head, and then the oxygenation module was inspected visually.Formation of blood clots was not observed.The actual sample after rinsed and dried was tested for its gas transfer performance in accordance with the factory's inspection protocol.As a result, the obtained values met the factory specifications, and no anomalies were revealed.[bovine 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= 366 ml/min.@4l/min= 260 ml/min.[co2 removal volume] @6l/min= 316 ml/min.@4l/min= 236 ml/min.Review of the provided pump record revealed: at 11:27 when paco2 was 67 mmhg, the circulation condition was as follows.Blood flow rate=4.17 l/min and gas flow rate=2.0l/min.The arterial blood temperature=14.0°c, which was the lowest temperature throughout this procedure.13:10 when rewarming started, paco2 was 34.7 mmhg, blood flow rate=1.12 l/min, gas flow rate=8.5 l/min, and arterial blood temperature=36.6°c.From 11:27 until 13:10, pao2 was maintained over 382mmhg and did not tend to decrease.As it was pointed out, paco2 increased while the arterial blood temperature was low, but pao2 did not decrease.Therefore, the increase in paco2 was considered to be due to the arterial blood temperature.A review of the device history record and 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.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 reason for the increase in paco2 during the low arterial blood temperature is conceivable that the low blood temperature made co2 easily soluble in the blood, i.E., co2 was difficult to remove.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

• 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: 12802271
• MDR Text Key: 282208218
• Report Number: 9681834-2021-00191
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: CX-XRX51804
• Device Lot Number: 210702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 67 KG