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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-RX25RW
Device Problem Increase in Pressure (1491)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2019
Event Type  malfunction  
Manufacturer Narrative
Udi not required for product code; implanted date: device was not implanted; explanted date: device was not explanted. The actual device was received for evaluation. Visual inspection revealed no obvious anomalies, such as a break, in the appearance. Physiological saline solution was let to flow into the blood channel by gravity drop. Visual inspection of the oxygenation module did not find any blood clot on that area. The actual sample before being rinsed was built into a circuit with tubes. Physiological saline solution was circulated in the circuit, while the pressure drop was determined at each flow rate. The obtained values were confirmed to be slightly higher than those obtained from a current product sample. The actual sample, after having been rinsed and dried, was built into a circuit with tubes. Bovine blood (hb12g/dl and temp. 37 deg. C) was circulated in the circuit, while the pressure drop was determined at each flow rate. The obtained values were confirmed to meet the factory's specifications. No obstruction was observed. Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings. Ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system. Do not reduce heparin during circulation. Otherwise, blood clotting might occur. 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. White substances were observed on the competitor's arterial filter, and the issue was found just before the end of the procedure, it is likely that the circuit was obstructed due to some factors and, as a result, the increase in the pressure drop occurred. 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 open heart surgery when the roller pump was operated, the pressure of the oxygenator increased. The pressure of the arterial filter in a competitor's circuit also increased. They finished the procedure without exchanging the oxygenator since the issue occurred just before the end. In addition, it was reported that white substances were observed on the arterial filter. There was no harm to the patient. The procedure outcome was not reported.
 
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Brand NameCAPIOX RX 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 Key9254782
MDR Text Key219164464
Report Number9681834-2019-00185
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040210
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 10/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Catalogue NumberCX-RX25RW
Device Lot Number181206
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2018
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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