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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameCAPIOX FX25 OXYGENATOR
Type of DeviceOXYGENATOR, 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 Key11063893
MDR Text Key234258107
Report Number9681834-2020-00263
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071572
Number of Events Reported1
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 Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX-FX25E
Device Lot Number200618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2020
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
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