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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*FX25RW
Device Problem Decrease in Pressure (1490)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2020
Event Type  malfunction  
Manufacturer Narrative
Device expiration date - unknown due to unknown lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacturer date - unknown due to unknown lot number. Occupation- chief perfusionist. Pma/510(k)- k130520. 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 production lot number was not provided by the user facility, which prevented a meaningful review of the device history record. (b)(4).
 
Event Description
The user facility reported that the capiox device was used pre-treatment. Chief perfusionist: pressure alarm at a flow of 4. 5 liters during the priming phase. Priming volumes: 1500ml jonosteril (carbohydrate electrolyte solution) 250ml / 15% mannitol solution 40ml / 8. 4% sodium hydrogen carbonate 10. 000 heparin complete hlm & set exchanged terumo tubing pack set: cxge272 / lot#: 2006330. 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
MDR Report Key11192336
MDR Text Key280446572
Report Number9681834-2020-00273
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX25RW
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No

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