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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-FX15RW40V
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
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 no obvious anomaly, such as a break, in the appearance. The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance with the manufacturer shipping inspection protocol: bovine blood arranged to hb 12. 0g/dl, temp. 37deg c. , ph:7. 4, svo2: 65% and pvco2:45mmhg was circulated in the oxygenator module under the following conditions: @ v/q
=
1, fio2
=
100% and the flow rate of 5l/min. And 3l/min. Result: o2 transfer: @5l/min.
=
307ml/min. @3l/min.
=
206ml/min, co2 removal: @5l/min.
=
264ml/min. @3l/min.
=
178ml/min. No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the manufacturer specifications. A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings. Review of the pump record involved in this complaint revealed that during the first 40 minutes, paco2 was high, but tended to decrease gradually. Pvco2 data was not included in the record; regarding pao2, no decreasing trend was observed though circulation was done with fio2 around 50%. 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. 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 the normal product. It is likely that since co2 gas was blown during the priming, pco2 contained in the priming solution had increased, and pvco2 immediately after the start of circulation was high, the paco2 was high accordingly; or gas flow rate was insufficient due to low v/q. 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 that after setting the capiox oxygenator and tubing, co2 was flushed to expel air before the priming process. After that, 3l of o2 was blown to expel co2. Hi in co2 was shown during cdi calibration. Despite re-flushing with 3. 5l, it was not improved. Though the situation was not improved, the pump was started at 12:10 with fio2 60% x 2l. Pco2 was 71. 4 at 12:19. No issue was found in the oxygenation performance. At 12:20, fio2 was changed to 45% x 5l. As a result, pco2 become 50-60mmhg, which was higher than the hospital standard of 40-50mmhg. Normally, gas flow rate is controlled to become half of the blood flow rate; however, in this case, they were necessary to be kept around 1:1 - 1: 1. 2. Without increasing o2, co2 could not be expelled. Gas was apparently difficult to be expelled. Issue was coped by increasing gas flow rate. The oxygenator was not exchanged. 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
theresa mussaw
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key9552419
MDR Text Key216656614
Report Number9681834-2019-00234
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 01/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue NumberCX-FX15RW40V
Device Lot Number190516
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2019
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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