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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORP. CAPIOX FX25 ADVANCE OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORP. CAPIOX FX25 ADVANCE OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3CX*FX25REC
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Information (3190)
Event Date 06/10/2019
Event Type  Injury  
Event Description
Product failure - terumo capiox fx25 oxygenator. (b)(4).
 
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Brand NameCAPIOX FX25 ADVANCE
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORP.
elkton MD
MDR Report Key8703623
MDR Text Key148279731
Report NumberMW5087383
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Model Number3CX*FX25REC
Device Lot NumberXC18
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/14/2019 Patient Sequence Number: 1
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