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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*RX25RW
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Health professional: requested, not provided. Occupation: requested, not provided. 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. A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings. (b)(4).
 
Event Description
The user facility reported that the capiox device was used pre-treatment and there were air bubbles in the oxygenator. The user started priming by running the main pump. After around 30minutes, there was evidence of an air bubble that appeared in membrane oxygenator. The user immediately stopped the pump and changed the oxygenator only with other capiox set and remained the reservoir to proceed with the procedure. The case was successful, and the patient was reported to be safe and was not harmed.
 
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Brand NameCAPIOX RX25 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
mary o'neill
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key12364255
MDR Text Key268044086
Report Number9681834-2021-00148
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K040210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*RX25RW
Device Lot Number201203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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