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

Model Number N/A

Device Problem Increase in Pressure (1491)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth, sex, ethnicity& race requested, unknown.Device lot number & expiration date requested, unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: perfusionist.Device manufacture date: unknown due to unknown lot number.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 manufacturing record and the shipping inspection record of the actual sample could not be reviewed since the involved lot number was unknown.A search of the past complaint file could not be searched since the involved lot number was unknown.(b)(6) (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 the capiox device involved had high pressure.There was difficult cannulation, arterial 21 for hls cannula arterial femoral is right.Venous cannulation very difficult, initially (for almost thirty (30) minutes) venous backflow was only possible via suction.Cannulation was done via the superior and inferior vena cava.To obtain better venous return, the venous vacuum therapy (sevaco) was applied.Continuous blood clots were suctioned via three suction units.Blood flow at the beginning was about 70% (=3.7 l/min), later with sufficient backflow it was 100% (=5-5.3 l/min).Act was in the normal range (=>500 s) except for the last 344s; therefore 5000 iu heparin was administered.Time on bypass was 249 minutes.Aortic clamp time was 97 minutes.Reperfusion time was 80 minutes.After about 2 hours of bypass time, it was noticed that the blood bag was inflated.Thus, it was inferred it had to be an overpressure on the side of the cardiotomy reservoir.The pressure was so high that the blue end cap was catapulted 3/8 inch off the reservoir.After increasing the suction several times from -25 mmhg to finally -80 mmhg; however, there was no improvement.The removal of the sevaco tube did not lead to an improvement.It was inferred that the filter in the cardiotomy reservoir was completely blocked and therefore impermeable to the patient's blood.Filling the reservoir via the inlet port was only possible with great pressure.The inlet tube was swapped to the front vent port of the venous reservoir and to open the luer lock plug on the opposite side.The surgical side reported that no coagulum was visible in the site.Replacing the reservoir was considered; however, the emergency cardiovascular care ecc could be ended prior.After the end of the emergency cardiovascular care ecc, the reservoir was emptied and a large amount (500-1000 ml) of non-coagulated blood came out of the cardiotomy reservoir.Fibrin threads were found in the cell saver drainage bag, which closed the drainage valve.There was no patient injury or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to report that this reported event has been reassessed and deemed not reportable based upon the investigation of the actual sample.This report is being submitted to provide the device return date in section d9 and update h3.Our inspection of the returned sample found that it was not ashitaka's but a tcvs's product and the reported complaint has been confirmed to have nothing to do with ashitaka's products.

• Brand Name: CAPIOX FX OXYGENATOR
• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16374079
• MDR Text Key: 309969972
• Report Number: 9681834-2023-00017
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: 04987350701022
• Combination Product (y/n): N
• Reporter Country Code: LU
• 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,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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*FX25RE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 5000 IU HEPARIN
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 96 KG