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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 Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
Manufacturer Narrative
Date of birth - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k)- k130520. The actual sample was received for evaluation. Visual inspection revealed no break or no other obvious anomaly in it. The actual sample, after having been rinsed and dried, was tested for its o2 transfer volume and co2 removal volume in accordance with the factory's inspection protocol. As a result, the obtained values were confirmed to meet the factory's control criteria. No anomaly in the gas transfer performance was observed. [bovine blood conditions] hb:12g/dl, temp. :37°c. , ph:7. 4, svo2:65%, pvco2: 45mmhg. [circulation conditions] blood flow rate: 6 l/min and 4 l/min, v/q
=
1, fio2
=
100%. [o2 transfer volume] @6 l/min
=
386 ml/min. @4 l/min
=
274 ml/min. [co2 removal volume] @6 l/min
=
312 ml/min. @4 l/min
=
233 ml/min. Record review: review of the picture of the blood gas data revealed: the circulatory conditions were unknown. Pco2 was high at 91. 6 mmhg at 13:30 (time indicated in the note). Po2 at 13:23 actual time (at 13:35 time indicated in the note) was 79 mmhg. Fio2 was 60% and po2 was 229 mmhg. Pco2 at 13:59 actual time was 58mmhg, and at 14:02 was 47mmhg. From the above data, there was no abnormality in po2 and no increase in temperature (not at the time of rewarming) a review of the device history record and the incoming inspection record of the involved product code/lot# combination was conducted with no findings. Ifu states: 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. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. The investigation results verified the returned sample was of normal product. No anomaly was observed in the po2 value. As it was most unlikely that only the co2 removal performance decreased while the oxygenation capacity was normal, it was conceivable that there was no anomaly in the actual oxygenator sample. In addition, as it did not occurred during rewarming, rewarming was not the factor of the reported issue. It is likely that he pco2 of the blood in the surgical field had increased due to co2 gas being blown into the field. When the blood containing increased pco2 and the co2 gas in the surgical field were suctioned into the reservoir, the pco in the blood in the reservoir increased, and then, the blood flowed into the oxygenator, the pco2 of bg increased. As an infusion fluid, solution containing sodium bicarbonate was added, leading to increasing pco2. 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 capiox device was used during the procedure. During cpb, the perfusionist found pco2 was higher than normal value. He increased the gas flow, although the pco2 decrease slowly. The patient was not harmed. The procedure outcome was not reported.
 
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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 Key12505066
MDR Text Key273340948
Report Number9681834-2021-00158
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX25RW
Device Lot Number201214C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2020
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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