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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0434
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 05/30/2018
Event Type  Death  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy a "blood detected" alarm was generated which caused interruption of therapy. There was no blood seen by the clinician. The customer attempted to restart the iab pump by powering down and rebooting the system. The customer also used the help feature to troubleshoot. Therapy was reinitiated however it was interrupted for 5-6 minutes. The patient expired however the patient's death is not attributed to the device by the facility.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. The extension tubing was also returned. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and no leaks were detected. The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle. The iab pumped normally and no alarm sounded from the pump. The reported alarm, blood detected event cannot be confirmed by the evaluation. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. Complaint # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy a "blood detected" alarm was generated which caused interruption of therapy. There was no blood seen by the clinician. The customer attempted to restart the iab pump by powering down and rebooting the system. The customer also used the help feature to troubleshoot. Therapy was reinitiated however it was interrupted for 5-6 minutes. The patient expired however the patient's death is not attributed to the device by the facility.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7648692
MDR Text Key112698500
Report Number2248146-2018-00409
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/27/2019
Device Catalogue Number0684-00-0434
Device Lot Number3000038925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/28/2018 Patient Sequence Number: 1
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