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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 Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation - chief perfusionist. Pma/510(k)- k071494, k130520. The actual device has not returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. Review of the provided image of the actual product confirmed the leak from the purge. A review of the manufacturing record and the product release judgement record of the involved product/lot# combination confirmed there was no indication of anomaly in them. A search of the complaint file found no similar report with the involved product code/lot# combination from other facilities. Since no anomaly was confirmed in the manufacturing related records, it is considered at this stage that this was not a product problem. (b)(4).
 
Event Description
The user facility reported that at the at the time of priming the fx 25 oxygenator with crystalloid fluid, there was a clear leakage from the oxygenator recirculation line at the proximal point of the oxygenator. It seems the connector was broken resulting in fluid leakage from the recirculation line. The oxygenator got replaced before the initiation of cpb. The event occurred pre-treatment. The patient final impact was not harmed. There was no patient injury, medical/surgical intervention required.
 
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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
stephanie handy
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
9499890491
MDR Report Key14163447
MDR Text Key289756524
Report Number9681834-2022-00065
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier04987350701046
UDI-Public04987350701046
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K071494
Number of Events Reported1
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,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX25RW
Device Lot Number210831
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2021
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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