• 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 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 FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX05RW
Device Problem Failure to Prime (1492)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/28/2017
Event Type  malfunction  
Manufacturer Narrative
The actual sample was received for evaluation. Visual inspection revealed no anomalies. The actual sample was built into a circuit with tubes. The pressure drop was determined while bovine blood, with hct. @35% and temp. @37 oc, was circulated in the reservoir and the oxygenator module. The result was confirmed to meet the specifications. The blood flow rate of 1. 5 l/min. (the maximum value for fx05) was able to be achieved. The customer's complaint of a difficulty in increasing the flow rate higher than 450 - 500 ml was not duplicated. There is no evidence that this event was related to a device defect or malfunction. The exact cause of the reported event cannot be definitively determined based on the available information. The investigation result verified that the actual sample was the normal product. However, based on the provided information that a blood bag was used during priming, it is assumed that the blood used for priming may have formed clots in the reservoir and/or in the oxygenator module of the actual sample and obstructed them.
 
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. (b)(6). The actual device has not been returned to the manufacturing facility for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. For this reason code was used in the conclusions section. A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no findings. (b)(4).
 
Event Description
The user facility reported they were unable to prime the capiox device. The following information was provided by the user facility: approximatively after 5-7 minutes, before starting the right atrium cannulation, they observed the rising of resistance in the circuit with the level decreasing in the venous reservoir, with the impossibility flow rate increasing of the main pump more than 450-500 ml. After 3-4 minutes they observed red thrombotic deposition on the surface of the venous reservoir. The event occurred pre-treatment, and the patient was not harmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
MDR Report Key7210238
MDR Text Key284510219
Report Number9681834-2017-00279
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,foreig
Type of Report Initial,Followup
Report Date 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberCX*FX05RW
Device Lot Number170630
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-