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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number ZZ*FX15RW40
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  Injury  
Manufacturer Narrative
Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. 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. Regarding the involved fiber lot, the result of the performance test (gas transfer test with bovine blood (hb: 12g/dl, 37°c)) conducted in the factory's inspection was reviewed. It was confirmed that the performance value was within the manufacturer standard and no anomaly was observed. Ifu states: measure blood gases and make necessary adjustments as follows. Control pao2 by changing concentration of oxygen in ventilating gas using gas blender. To decrease pao2, decrease fio2. To increase pao2, increase fio2. Control paco2 by changing the total gas flow. To decrease paco2, increase total gas flow. To increase paco2, decrease total gas flow. It is likely that po2 in the blood aspirated from the thorax might have been low, thereby po2 of the blood in the circuit dropped also. However, with no device return 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. There was a malfunction of the oxygenator inserted inside the custom pack it365x lot 1912023. Surgery on an (b)(6)-year-old patient undergoing replacement of the vdx-pulmonary artery valve duct following previous surgery. After 4 and a half hours of cec where the parameters of po2 and pco2 were normal, about 2 liters of blood is aspirated from the pleura from that moment the po2 values begin to drop. Intervention conducted with co2 delivery in the chest with a variable flow between 5-10 l / min. Actual value always greater than 480 sec. The oxygenator has been replaced with another capiox fx15rw40 and in the maneuver approximately 300 ml of blood is lost. The patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX FX 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
265 davidson ave suite 320
somerset, NJ 08873
8002837866
MDR Report Key11567210
MDR Text Key242389799
Report Number9681834-2021-00048
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Catalogue NumberZZ*FX15RW40
Device Lot Number181113
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2018
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: 03/25/2021 Patient Sequence Number: 1
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