• 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 FX OXYGENATOR

  • 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 FX OXYGENATOR Back to Search Results
Catalog Number CX-FX25RE
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem Death (1802)
Event Date 07/11/2016
Event Type  Death  
Manufacturer Narrative
Udi no.- not required for this product.(b)(4).The actual device was discarded by the user facility.Therefore, the investigation was limited to assessment of the user facility information, photos of the actual device and the retention sample from the involved product code/lot# combination.Review of the photos found a fluid containing blood components inside the gas in-port side.The retention sample was subjected to visual inspection.No anomalies were confirmed.The retention sample was filled with saline solution and leak tested.No leak was confirmed.A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.A review of the pump record from the involved procedure did not contain any information which could lead to the reported phenomenon.Based upon the available information, the cause for the reported event cannot be definitively determined.There are many complex clinical variables that may have affected the reported observed conditions.However, there is no indication that the reported event was related to a product malfunction or defect.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Actual device discarded.
 
Event Description
The user facility reported a death during the use of a capiox device.Follow up communication with the user facility confirmed the following information: it was an aortic dissection case; the device did not pose any issue during the initial circulation; on the stage of re-circulation the gas transfer performance started to become degraded; the control was difficult with an application of 100% o2 sweep gas at 5l/min; fluid was noted to be pooled inside the outer housing of the oxygenator module; the procedure was finished without change-out of the device in question; and the patient ultimately expired.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAPIOX FX OXYGENATOR
Type of Device
OXYGENATOR
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA  418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA   418
Manufacturer Contact
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key5871316
MDR Text Key51934772
Report Number9681834-2016-00188
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 08/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2019
Device Catalogue NumberCX-FX25RE
Device Lot Number160211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/13/2016
Initial Date FDA Received08/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TRIPLEX
Patient Outcome(s) Death;
Patient Age72 YR
Patient Weight70
-
-