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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 11/09/2021
Event Type  malfunction  
Event Description
The user facility reported the capiox device was used during the procedure. During perfusion there were noticeable high co2 values. The high values could only be regulated with difficulty: with a gas flow of 8-10l/min. Also, during these surgical procedures, co2 is also introduced into the open thorax (the usual procedure when the heart cavities are open to avoid air embolism later on). Oxy was not part of the terumo tubing pack set. No significant delay of surgery. The patient's treatment was performed as planed and finalized. The oxy was not replaced. The procedure was completed successfully. The patient was not harmed.
 
Manufacturer Narrative
Expiration date - unknown due to unknown lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k)- k130520. Device manufacturer date - unknown due to unknown lot number. The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record. Ifu states: measure blood gases and make necessary adjustments as follows. B. Control paco2 by changing the total gas flow. To decrease paco2, increase total gas flow. To increase paco2, decrease total gas flow. From the information that "during these surgical procedures, co2 gas was blown into the surgical field", it was thought that co2 gas and blood with increased pco2 were aspirated into the reservoir, and the blood with increased pco2 may have flowed into the oxygenator. However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information. Terumo medical products (tmp) (importer) registration no. (b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no. (b)(4).
 
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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
mary o'neill
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key13017254
MDR Text Key287272068
Report Number9681834-2021-00245
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX25E
Was Device Available for Evaluation? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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