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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 Problem Device Displays Incorrect Message (2591)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 07/19/2017
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.We continue our efforts to follow up with the customer for its return.Complaint # (b)(4).
 
Event Description
It was reported by the customer reported that during intra-aortic balloon (iab) therapy, therapy was discontinued because of multiple alarms.The alarms that were generated were "iab disconnected" and "fiber optic sensor failure".The patient was coding at the time of therapy.The patient expired, but the death is not attributed to the device by the facility.
 
Manufacturer Narrative
09/15/2017 (b)(4): upon submission of the initial emdr the device return was not noted.The device was returned on 7/28 and at the time of previous submission was pending evaluation.The device evaluation is complete as noted below.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.Two kinks were found on the catheter tubing approximately 58.7cm and 75.7cm from the iab tip.The optical fiber was found to be broken at this location.The inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.We were unable to confirm the iab disconnected alarm.The optical fiber was found to be broken, confirming the reported sensor failure.It is difficult to determine when or how a break in the fiber optic occurs.However, a kink in the catheter can cause the fiber optic to break resulting in no signal or the inability to calibrate it.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 by the customer reported that during intra-aortic balloon (iab) therapy, therapy was discontinued because of multiple alarms.The alarms that were generated were "iab disconnected" and "fiber optic sensor failure".The patient was coding at the time of therapy.The patient expired, but the death is not attributed to the device by the facility.
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, 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 Key6771724
MDR Text Key81967931
Report Number2248146-2017-00212
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 Nurse
Type of Report Initial,Followup
Report Date 09/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/19/2020
Device Catalogue Number0684-00-0575
Device Lot Number3000054323
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
Patient Weight99
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