MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX25W

Device Problem Pressure Problem (3012)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number: 220308, 220414.Expiration date: 02/28/25, 03/21/25.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation - clinical engineer.Pma/510(k) - k130280.Device manufacture date: 03/08/2022, 04/14/2022.The actual device was not available; therefore, the actual device will not be returned for evaluation.Review of the manufacturing history record and the shipping inspection record of the actual product confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report for the involved product code/lot number combination.The pump records were reviewed, and the pre-oxygenator pressure and post-oxygenator pressure were compared.It was found that there was a period of time when post-oxygenator pressure was higher than pre-oxygenator pressure.When the flow rate was increased to approx.4.2 l/min after the start of extracorporeal circulation, the pressure value increased in line with the increase in flow rate.At that time, the pressure loss (pre-oxygenator pressure - post-oxygenator pressure) was 7mmhg.A simulation test was performed using a current product oxygenator, referring to the circulation condition during the time when the post-oxygenator pressure was higher than the pre-oxygenator pressure.[circulation conditions] hb: 12g/dl, temp.: 35°c, blood flow rate: 4.2l/min.[pressure during circulation] pre-oxygenator pressure: 203mmhg, post-oxygenator pressure: 196mmhg.The pressure loss when bovine blood flowed was measured referring to the data at the start of extracorporeal circulation.It was found that the pressure loss was 47mmhg, which was higher than the pressure loss when using the involved product.The pre-oxygenator pressure when bovine blood was passed through the oxygenator was confirmed so that the blood flow rate was 4.2l/min and the post-oxygenator pressure was 196mmhg.It was found that it was 240mmhg, which was different from the pre-oxygenator pressure at the time of use the involved product.The post-oxygenator pressure when bovine blood was passed through the oxygenator was confirmed so that the blood flow rate was 4.2l/min and the pre-oxygenator pressure was 203mmhg.It was found that it was 158mmhg, which was different from the post-oxygenator pressure at the time of use the involved product.Based on the investigation result, no anomaly was found in the manufacturing records of actual product.As a cause of occurrence, since the actual product could not be confirmed and the conditions under which it was used could not be simulated, it was not possible to identify the cause.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 9681834-2022-00199.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 the pre-oxygenator pressure on the capiox fx25 device involved was lower than the oxygenator exit pressure during priming.It was conceivable that the inline pressure sensor (senko medical instrument) had a defect.The pressure sensor from the side branch of oxygenator was attempted for use; however, the condition was the same.Considering the possibility of defect of the oxygenator, the oxygenator was replaced.The pressure change of the replaced oxygenator was the same as before the replacement; however, after the pump was turned on, the pressure became close to normal.The event occurred intra-operative.There was no patient injury/medical or surgical intervention was required.The procedure outcome was not reported.The final patient impact was unknown.

• Brand Name: CAPIOX FX25 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 ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15606216
• MDR Text Key: 307262608
• Report Number: 9681834-2022-00205
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-FX25W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• 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
• Treatment: HASII; INLINE PRESSURE SENSOR (SENKO MEDICAL INSTRUMENT)