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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-FX25RWV
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2021
Event Type  malfunction  
Manufacturer Narrative
Patient identifier - requested, not provided. Age & date of birth - requested, not provided. Patient sex - requested, not provided. Weight - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- clinical engineer. Pma/510(k)- k130280. 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 the product-release judgement record of the involved product code/lot# combination was conducted with no findings. Ifu states: start gas supply with v/q
=
1, and fio2
=
100%, then make adjustments based on blood gas measurements. Measure blood gases and make necessary adjustments as follows. A. Control pao2 by changing concentration of oxygen in ventilating gas using gas blender. To decrease pao2, decrease fio2. To increase pao2, increase fio2. B. Control paco2 by changing the total gas flow. To decrease paco2, increase total gas flow. To increase paco2, decrease total gas flow. A phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers. This may occur when oxygenators are used for a longer period of time. If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance. Increase gas flow rate, to 20 l/min for 10 seconds. Do not repeat this flushing technique, even if oxygenator performance is not improved. Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patients metabolism. Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism. 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).
 
Event Description
The user facility reported that the capiox device was used during the procedure. In less than three hours from cpb started, oxygenation performance was seen decreasing. There was no plasma leak observed. Considering that replacing oxygenator might have involved risks, they decided to wean the patient. The procedure outcome was not reported. The patient was not harmed.
 
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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 Key11640016
MDR Text Key261952721
Report Number9681834-2021-00056
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071572
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 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX-FX25RWV
Device Lot Number201029
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 Received03/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2020
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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