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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT) OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT) OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 1CX*RX25RW
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
The user facility reported that during priming of the capiox device, there was air coming from arterial outlet. There was no delay in the procedure, the product was changed out and the surgery was completed successfully with no patient effect, there was no blood loss.
 
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- technologist. 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 decision control sheet 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 1l/min. Minimum operating volume in the reservoir is 200ml. Set appropriate blood storage level, relative to venous flow rate, to prevent gaseous emboli passing to patient. Recirculate the priming solution at a rate of 4l/min or higher to facilitate air removal. Failure to remove air from the oxygenator may result in serious injury to the patient. Ensure that the de-airing process is complete prior to initiating bypass. With no device return the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
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Brand NameCAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT)
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 Key13060382
MDR Text Key289495511
Report Number9681834-2021-00253
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K040210
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
Report Date 12/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1CX*RX25RW
Device Lot Number950823
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2021
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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