• 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 FX25 OXYGENATOR 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 FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX25RW
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2022
Event Type  malfunction  
Event Description
The user facility reported that during the priming step with the oxygenator involved, a leak was noticed on the oxygenator side near the temperature side. The red port was attempted to be tightened, but the slow leak still occurred. The decision was made to changeout as the patient was going to be on bypass very soon. There was no patient involved. The procedure outcome was not reported. The patient was not harmed.
 
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Health professional - requested, unknown. Occupation - requested, unknown. Pma/510(k)- k130520. 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. The provided image showed that water droplets had occurred inside the housing of the actual oxygenator sample. However the leakage point could not be identified from the image. A review of the manufacturing record and the product-release judgement record of the involved product /lot number combination confirmed that there was no anomaly in them. A search of the complaint file found no other similar complaints with the involved product /lot number combination. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAPIOX FX25 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
stephanie handy
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
9499890491
MDR Report Key14204713
MDR Text Key290538532
Report Number9681834-2022-00069
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier04987350701046
UDI-Public04987350701046
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX25RW
Device Lot Number210908
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-