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

Model Number N/A

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: requested, not provided.Patient date of birth: requested, not provided.Patient ethnicity: requested, not provided.Patient race: requested, not provided.Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: clinical engineer.Pma/510(k): k130280.Visual inspection of the actual sample found no breakage leading to gas transfer failure.After rinsing and drying the actual sample, the amount of oxygen transfer and carbon dioxide gas removal were measured when bovine blood was flowed into the actual sample.It met the factory's specifications.No anomaly was found in the gas transfer performance.[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: 117ml/min., @1l/min: 65ml/min.[co2 removal volume] @2l/min: 95ml/min., @1l/min: 55ml/min.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report with the product of the involved product code/lot number was found.Based on the investigation result, no anomaly was found in the gas transfer performance of actual sample after rinsing and drying.As a possible cause of this case, it was likely that due to some factors (e.G., blood clot, wet lung), the contact between blood and oxygen gas was hindered, and the gas transfer performance decreased.However, no anomaly was found in the actual sample after rinsing, and the cause of occurrence could not be clarified.Relevant instructions for use (ifu) reference: "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: 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." upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patient's metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism." terumo medical products (tmp) (importer) registration no.(b)(4)is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that after 174 minutes of pumping time, around ao declamp, there was concern that the pao2 did not increase.Around 16:00, as pco2 increased, fio2 and o2flow were raised, however, pco2 did not changed.At 16:40, fio2 was brought to 100%; however, pao2 was not increased.At 16:53, pao2 fell below 100 and heparin was administered.At 16:57, weaning had occurred and there was no pressure rise.After the weaning, the oxygenator was replaced, and a second pump was used.There was no problem at that time.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.The product malfunctioned due to gas transfer failure.The procedure outcome was not reported.The final patient impact was not harmed.

• 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: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16076148
• MDR Text Key: 306409255
• Report Number: 9681834-2022-00264
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX-FX05RW
• Device Lot Number: 220707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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
• Treatment: BLOOD CIRCUIT (SENKO MEDICAL INSTRUMENT MFG).; HEPARIN.
• Patient Age: 1 YR
• Patient Sex: Female
• Patient Weight: 10 KG