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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET GETINGE GROUP SENSATION PLUS 8 FR IAB CATHETER

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MAQUET GETINGE GROUP SENSATION PLUS 8 FR IAB CATHETER Back to Search Results
Model Number 0684-00-0576-01U
Device Problems Break (1069); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 07/24/2016
Event Type  Injury  
Event Description
On (b)(6) 2016 patient had a 50cc sensation plus iab catheter placed in the cath lab. On (b)(6) 2016 at approx. 0553 the balloon pump began to alarm "gas loss in circuit," at this time the respiratory therapist checked all the connections. No blood was found at this time. The balloon was auto filled, restarted and quickly alarmed again. Upon inspection the catheter and helium line were found to have blood in them. The pump was stopped and the catheter was clamped off to stop the backwards flow of blood. The cardiologist came in to replace the damaged balloon. When the second replacement balloon was inserted it was found to be damaged (torn). The third balloon was placed and therapy restarted. The patient was transferred back to cicu. On (b)(6) 2016 at about 1235 the pump once again began to alarm "gas loss in circuit. " it was quickly discovered that once again there was blood in the catheter and helium line. The therapist clamped the catheter and helium line. This catheter was removed by the physician. It was decided that it would not be replaced, as the plan was to remove it that day anyway. About an hour later, the patient coded and expired.
 
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Brand NameSENSATION PLUS 8 FR IAB CATHETER
Type of DeviceSENSATION PLUS 8 FR IAB CATHETER
Manufacturer (Section D)
MAQUET GETINGE GROUP
MDR Report Key5846122
MDR Text Key51241678
Report NumberMW5063832
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2019
Device Model Number0684-00-0576-01U
Device Lot Number3000032904
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 08/01/2016 Patient Sequence Number: 1
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