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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRX13801
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
Event Type  Injury  
Manufacturer Narrative
Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation-clinical engineer. Pma/510(k)- k130520. The actual sample was received for evaluation. Visual inspection upon receipt did not find any anomaly including a breakage in the appearance. The actual sample was built into a circuit with tube, and then normal saline was circulated at each flow rate while the pressure drop was determined. Compared to current product sample, no difference was observed in the obtained values. The actual oxygenation module was fixed by being filled with glutaraldehyde-containing normal saline, and then the housing and the filter were removed. Visual inspection of both sides of the filter found no deposit that could lead to the low gas transfer performance. The oxygenation module was visually inspected. No deposit that could lead to the low gas transfer performance was confirmed. No anomaly was noted in the state of fiber winding. The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections. No anomaly such as an obstruction in the flow path was observed. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. The pump record was reviewed, however, no factors that could lead to the low gas transfer performance could be read from the data. 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 pao2 by changing concentration of oxygen in ventilating gas using gas blender. To decrease pao2, decrease fio2. To increase pao2, increase fio2. 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. 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. It was likely that the gas transfer performance dropped gradually due to some factors. 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 while the involved capiox xrx13801 fx25 was being used, oxygenation performance became weakened. They judged that the procedure could not be continued with it and was replaced it with xsa99934, and then no further problem occurred. Observing no anomaly in the oxygenation performance at the start of use, they concluded that the event was not attributable to the fx25. No pressure rise was observed, however, they considered that something clogged with the actual sample leading to the oxygenation performance drop. The procedure was completed successfully. The patient was not harmed.
 
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Brand NameCAPIOX CUSTOM PACK
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 Key11419881
MDR Text Key238923893
Report Number9681834-2021-00023
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 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX-XRX13801
Device Lot Number200827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2020
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: 03/05/2021 Patient Sequence Number: 1
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