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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 1ZZ*FX05REA
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted; explanted date: device was not explanted. Occupation- ccp. The actual device has not been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. For this reason, investigation conclusions code has been referenced. A review of the device history record and product-release decision control sheet of the involved product code/ lot # combination was conducted with no findings. (b)(4).
 
Event Description
The user facility reported white clots forming outside of the capiox device fiber bundle of oxygenator. The event was found while patient was on bypass. The product was not changed out, and they continued using the oxygenator. There was no delay in the procedure, no blood loss, no patient injury. The surgery/procedure was completed successfully. Additional information was receive on 10-sep-2021. The perfusionist stated "a buddy of mine helped my figure out those globules, they may be fractured/ denatured vwf (von willebrand factor). Could this occur with certain, rare susceptible kids with higher flows (1. 5 - 2. 0 lpm) on the fx05? unconfirmed but plausible to further investigate. " vwf is a blood glycoprotein involved in hemostasis. Under high shear conditions, it promotes platelet aggregation. Additional information was received on 11-sep-2021. Product was not changed out, nothing was done. Ccp continued the case with the oxygenator.
 
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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
MDR Report Key12576622
MDR Text Key281928123
Report Number9681834-2021-00172
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K071572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1ZZ*FX05REA
Device Lot Number140760
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
Is This a Reprocessed and Reused Single-Use Device? No

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