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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX05RW
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k)- k130280. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. The actual sample in disassembled condition was received for evaluation and currently under investigation. The provided image showed that the venous inlet drop tube inside the venous filter was kinked. Visual inspection of the actual sample as revealed that one of the venous inlet drop tubes seemed to have been crushed at the root. A part of the defoamer was found to have been pushed inward when seen from the upper side. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. (b)(4).
 
Event Description
The user facility reported that the capiox device was used during the procedure. They had ran on bypass with the svc can and just inserted the ivc cannula, were expecting full flows, although could not be achieved. The case was on bypass about 30mins longer than it should have been while the issue was diagnosed. The venous line into the reservoir was bypassed so that we could achieve full flows. The surgery was completed successfully. There was no blood loss. The patient was not harmed.
 
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Brand NameCAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
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 Key12638250
MDR Text Key276598579
Report Number9681834-2021-00181
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K071572
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,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX05RW
Device Lot Number210120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
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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