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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0568-01
Device Problems Off-Label Use (1494); Calibration Problem (2890); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
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. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated an unable to calibrate optical sensor alarm. The insertion was reported to be axillary, which is not the method described in the device instructions for use. The customer was made aware of the off-label use and proceeded to troubleshoot as though it were a femoral insertion. Screenshots of console screen revealed it was functioning appropriately with an excellent, crisp arterial wave form and good afterload reduction. The customer mentioned that therapy had been started for over a week and they had not had any issues until today after the patient ambulated. It was noted that the fluid lumen had never been set up making it unusable and patient did not have another line. Cardiology fellow at the bedside ordered a chest film and stated that the catheter tip position had not changed. It was explained that due to the timing of the alarm, the catheter was likely kinked internally at some point. It was then suggested that they could put the pump in semi auto mode to silence the alarm. The customer opted to leave the pump as is. There was no patient harm or adverse event reported.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12275378
MDR Text Key264997814
Report Number2248146-2021-00490
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108063
UDI-Public10607567108063
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122628
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 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0568-01
Device Catalogue Number0684-00-0567
Device Lot Number3000129252
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/04/2021 Patient Sequence Number: 1
Treatment
UNKNOWN.
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