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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number ZZ*FX25RW
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
Udi not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation-chief perfusionist. Pma/510(k)- k130520. The actual device was not returned, therefore, an evaluation of the actual device was unable to be conducted. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. Ifu states: do not obstruct gas outlet port. Avoid build-up of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase. Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase. The gas flow rate should not exceed 20l/min. Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase. During recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force. To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line. The blood flow rate of the cardioplegia line should not exceed 1 l/min. Minimum operating volume in the reservoir is 200 ml. Set appropriate blood storage level, relative to venous flow rate, to prevent gaseous emboli passing to patient. Ensure that the de-airing process is complete prior to initiating bypass. With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported that the involved capiox device was used during the procedure. The chief perfusionist stated foam development for no apparent reason after approximately 45 minutes bypass time. Negative and positive pressure tests were performed, there was no leakage. The reservoir did not need to be replace. The type of intervention was a reconstruction of the pulmonary bifurcation. The blood loss was nominal, reconditioning cell saver. There was no significant delay in the surgery. The procedure was completed successfully. The patient was not harmed.
 
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Brand NameCAPIOX FX25
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
265 davidson ave suite 320
somerset, NJ 08873
8002837866
MDR Report Key10596171
MDR Text Key208862348
Report Number9681834-2020-00191
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberZZ*FX25RW
Device Lot Number190712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2019
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: 09/28/2020 Patient Sequence Number: 1
Treatment
HEPARIN; TRANEXAMIC ACID
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