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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC.; TUBING, PUMP, CARDIOPULMONARY BYPASS
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MEDTRONIC, INC.; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HY6T48R10
Device Problem Disconnection (1171)
Patient Problem Blood Loss (2597)
Event Date 07/25/2018
Event Type  Injury  
Event Description
Patient was being transported from the operating room to the cardiac icu following surgery.The patient was just outside the icu room when the ecmo shunt line tubing became disconnected from the manifold.This resulted in air entrapment in the tubing and blood loss.Patient required about 5 minutes of cpr in order to retain life while the air was drawn back from the circuit and tubing was reconnected.Manufacturer response: for tubing, cardiopulmonary bypass, (brand not provided) (per site reporter).
 
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Brand Name
NA
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC, INC.
4340 swinnea rd ms ss-46
memphis TN 38118
MDR Report Key7817558
MDR Text Key118265177
Report Number7817558
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/01/2018
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 No Information
Device Model NumberHY6T48R10
Device Lot Number215510567
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/01/2018
Event Location Hospital
Date Report to Manufacturer08/27/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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