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

Catalog Number CX-FX25E

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- clinical engineer. Pma/510(k)- k130280. The actual device has been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. For a review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no findings. (b)(4).

Event Description

The user facility reported that the involved capiox device was used during the procedure. Bsa 1. 72. Blood gas test result with cdi500, 50 minutes after pump started: blood flow 4. 2l, gas flow 2. 5l, fio2 60%, pao2 around 250, and co2 around 50. After that, co2 increased to 80 while pao2 did not change. In order to decrease co2, another fx25 was added to return blood to the reservoir, however it could not be decreased as expected (from 80 to 70 only). After the first oxy was removed, circulation continued with the second oxy only, and pao2 and co2 became stable. No pressure drop was observed during ecc. Second fx25 was added to the arterial side. Oxygenated blood was returned to the reservoir and then pumped through the first oxy. After that, the first oxy was removed and circulation was done with the second oxy only. The patient was not harmed. The procedure outcome was not reported.

• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11063893
• MDR Text Key: 234258107
• Report Number: 9681834-2020-00263
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CX-FX25E
• Device Lot Number: 200618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/23/2020 Patient Sequence Number: 1