• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX05RE
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Phone number- requested, not provided. Occupation- chief perfusionist. 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. 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 small red clots that was visible on the side of the oxygenator membrane. The event occurred during cardiopulmonary bypass, there was no delay in the procedure, the product was not changed out and the surgery was completed successfully with no patient effect. There was no blood loss.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13224830
MDR Text Key287897976
Report Number9681834-2021-00262
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier04987350781758
UDI-Public04987350781758
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Catalogue NumberCX*FX05RE
Device Lot Number191121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-