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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 CX-XRX25403
Device Problem Infusion or Flow Problem (2964)
Patient Problem Blood Loss (2597)
Event Date 02/14/2019
Event Type  Injury  
Manufacturer Narrative
Patient identifier - requested, not provided. Age & date of birth - requested, not provided. Sex - 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. 510(k): k130520. The actual sample was received for evaluation. Visual inspection revealed that there were no anomalies. Saline solution was let to flow through the actual device by gravity. Another visual inspection of the actual found that some clots had formed inside the oxygenator module. The actual device, after having been rinsed and dried, was tested for the gas transfer performance by circulating bovine blood (@ hb12g/dl and 37ocin it, at the flow rate of 6l/min and 4l/min, under the conditions of fio2
=
100%, v/q
=
1. Both o2 transfer and co2 removal in volume were confirmed to meet manufacturer specifications. Review of the profusion record revealed the following: after 18:44, there are some points of time when both pao2 and svo2 dropped. Review of the events at those points of time found that the drops in pao2 and svo2 had occurred around the initiation of the extracorporeal circulation. In the record, a star-mark was found to have been put at 20:08, when another extracorporeal circulation was started. Pao2, which was 181mmhg at 20:08 was found to have dropped to 27mmhg at 20:09. There was no indication of the sao2 values from 20:09 to 20:15. A review of the device history record of the product code/lot# combination was conducted with no findings. 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. There is no evidence that this event was related to a device defect or malfunction. The investigation results verified the returned sample was of the normal product, with no anomaly with its gas transfer performance. Based on the investigation results, it is likely that blood of which svo2 had become lower entered the oxygenator module at the initiation of the extracorporeal circulation, resulting in the dropped pao2. However, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported the involved capiox pack was used during an aortic arch artery replacement case. Due to the slow progress of the procedure, ceases and re-dos of the circulation were repeated. After the third cease of circulation, when the circulation restarted, the o2 transfer performance became degraded. Cooling down did not help the pao2 to be recovered. The actual sample was changed out. The procedure was completed successfully. There was some blood loss due to change-out of the device. The patient was not harmed.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
mark vornheder
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
8002837866
MDR Report Key8390350
MDR Text Key137833808
Report Number9681834-2019-00031
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
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 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberCX-XRX25403
Device Lot Number181114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2018
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: 03/05/2019 Patient Sequence Number: 1
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