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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INC. PERFUSION OPEN HEART PACK - OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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MEDTRONIC INC. PERFUSION OPEN HEART PACK - OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number TL5X08R11
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  Injury  
Event Description
On (b)(6) 2018 the patient underwent an aortic and mitral valve replacement. Immediately upon undergoing cardiopulmonary bypass, there was a difficulty maintaining the patient's oxygenation. A thorough inspection machine revealed that the piece of the oxygenator was broken. The patient was taken off the bypass machine and the oxygenator was replaced. The procedure continued and tolerated by the patient fairly well. Post procedure the patient was transferred to cvicu.
 
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Brand NamePERFUSION OPEN HEART PACK - OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC INC.
MDR Report Key7540337
MDR Text Key109281470
Report NumberMW5077416
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 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/02/2019
Device Model NumberTL5X08R11
Device Lot Number214315945
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 05/23/2018 Patient Sequence Number: 1
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