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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*RX25RE
Device Problem Decrease in Pressure (1490)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The actual sample was received for evaluation. Visual inspection revealed that no damage or other anomalies leading to pressure drop. The actual sample was rinsed, the blood channel was filled with normal saline (colored for better visibility), the blood outlet port was occluded, and then air pressure of 2kgf/cm2 was applied to the blood channel from the blood inlet port. As a result, no leak occurred. The actual sample was built into a circuit with tubing, and then the pressure loss was measured while bovine blood (hct 35%, temp. 37°c) was circulated at each flow rate. The results were within the manufacturers specifications, and no anomaly was found that would lead to a pressure drop. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. 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. 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 pre-treatment; while the user was priming the capiox device, the pressure of the oxygenator or circuit decreased. They found that the oxygenator's arterial tubing value downing during the priming procedure. The procedure was completed successfully. The patient was not harmed.
 
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Brand NameCAPIOX RX25 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
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key12279498
MDR Text Key265164908
Report Number9681834-2021-00128
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K040210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*RX25RE
Device Lot Number210120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
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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