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

Model Number N/A

Device Problem Gas Output Problem (1266)

Patient Problem Septic Shock (2068)

Event Type  Injury  

Event Description

The user facility reported that the capiox device involved was being used during a cardiopulmonary bypass producer when the oxygenator failed.The oxygenator failure did not cause or contribute to an injury or patient death.The patient was septic.

Manufacturer Narrative

Weight - 12.2 kg lbs.Implanted date: device was not implanted.Explanted date: device was not explanted.Phone number: requested, unknown.Occupation: ccp.Device manufacture date: unknown due to unknown lot number.Additional informtaion - patient's height: 84 cm.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Since the involved lot number was not identified, the review of manufacturing records could not be performed.Regarding the product code involved, a review of the complaint record found no other similar reports.The following information was obtained from the provided pump record.The patient's height, weight and bsa.The target perfusion rate was 1.33l/minute.The bypass started at 5:51 and [°c cool/warm] was a 32.Afterward, at 8:17, the [°c cool/warm] was a 37, which indicated that the rewarming started.Po2 was found to decrease as follows: (i) 417 mmhg at 8:24; (ii) 211 mmhg at 8:35; (iii) 117 mmhg at 8:57.At 9:01, the malfunction of the oxygenator was noted in the record.The flow rate at that time slot was gradually decreasing from 1.3l/minute, and the gas flow rate was 0.8l/minute.The oxygenator in question was replaced at 9:50.As a possible cause of this complaint, the following factors were considered; however, since the actual sample was not returned for analysis, the definite cause of occurrence could not be determined.The patient's metabolic rate increased due to rewarming, resulting in insufficient oxygen supply for oxygen consumption and consequent low po2.During rewarming, the blood flow rate was low for the patient's bsa, and the gas flow rate was low for the blood flow rate.For your reference, the instructions for use (ifu) for capiox fx05 includes the following precaution: (i) a."start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements." (ii) b."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 (d.During perfusion)." (iii) "upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increasing in patient's metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed to the amount of the patient's gaseous metabolism.(precaution)." (b)(4).

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14737005
• MDR Text Key: 295030776
• Report Number: 9681834-2022-00114
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350739087
• UDI-Public: 04987350739087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1CX*FX05RWA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 12 KG