• 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 RX 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 RX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*RX05RW
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Date 03/09/2019
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Reporter name: unknown.Health professional: unknown.Initial reporter occupation: unknown.510(k): k122590.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the retention sample from the involved product code/lot# combination.Visual inspection revealed there were no anomalies, such as a break, in the appearance.The sample was tested for its gas transfer performance in accordance with the manufacturer shipping inspection protocol.Bovine blood arranged to hb12.0 g/dl, temperature 37oc., ph:7.4, svo2:65% and pvco2:45mmhg was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flow rate of 2l/min.And 1/min.The following results were found: o2 transfer: @2l/min.= 118ml/min.@1l/min.= 68ml/min.Co2 removal: @2l/min.= 97ml/min.@1l/min.= 57ml/min.No anomalies were revealed in the gas transfer performance of the retention sample, with the obtained values meeting the manufacturer specifications.A review of the device history record and the product release decision control sheet of the reported product code/lot number combination was conducted with no findings.Ifu states: measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.This investigation results verified the retention sample was of the normal product.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
 
Event Description
The user facility reported that the perfusionist changed out the capiox oxygenator; after initiating the bypass initial po2 was 250, and after thirty minutes po2 dropped down to 45 mmhg.The procedure outcome and patient outcome was unknown.Blood loss was not reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAPIOX RX OXYGENATOR
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
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
theresa mussaw
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
4103927218
MDR Report Key8458989
MDR Text Key140140098
Report Number9681834-2019-00043
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier04987350763471
UDI-Public04987350763471
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K022115
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 03/28/2019
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 Date08/31/2021
Device Catalogue NumberCX*RX05RW
Device Lot Number180912
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/09/2019
Initial Date FDA Received03/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-