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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Failure to Calibrate (2440); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. One kink was found on the catheter tubing approximately 55. 1cm from the iab tip. Dried blood was found occluding the inner lumen. The occlusion was able to be cleared. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. A sensor output test was performed and the sensor was found to be within specification. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. 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); record # (b)(4).
 
Event Description
It was reported that on (b)(6) 2017 an intra-aortic balloon (iab) catheter was inserted without difficulty. Although the iab was inserted successfully and connected properly pressure waveforms could not be seen on screen. The physician discontinued the therapy. It was later determined that the start button was never pushed on the intra-aortic balloon pump (iabp) therefore did not allow the autofill nor calibration to occur. A second balloon was inserted. There was no injury or harm to the patient.
 
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 on (b)(6) 2017 an intra-aortic balloon (iab) catheter was inserted without difficulty. Although the iab was inserted successfully and connected properly pressure waveforms could not be seen on screen. The physician discontinued the therapy. It was later determined that the start button was never pushed on the intra-aortic balloon pump (iabp) therefore did not allow the autofill nor calibration to occur. A second balloon was inserted. There was no injury or harm to the patient.
 
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Brand NameSENSATION PLUS 8FR. 50CC 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 Key6703163
MDR Text Key202680127
Report Number2248146-2017-00152
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Catalogue Number0684-00-0575
Device Lot Number3000046473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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