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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 Leak/Splash (1354); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)
Patient Problems Atrial Fibrillation (1729); Fever (1858)
Event Date 04/25/2018
Event Type  Injury  
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
The customer called our emergency support program and reported that during intra-aortic balloon (iab) therapy there had been several ¿leak in iab circuit¿ alarms generated. Each time they pressed the iab fill key and resumed support, the alarm returned after about 15 minutes. All connections were secure and there was no sign of a catheter leak. The doctor opened the chest at bedside due to severe constriction on the heart and aorta. The customer planned to exchange the console and the emergency service representative requested the customer to reduce the diastolic augmentation two clicks to see if this would help. The principal account manager followed up with the account and indicated that the alarm may have been related to the patient's condition. The patient has an underlying atrial fibrillation rhythm with rate in the 90s, was febrile with a temperature of 100. 5 that dropped from 101. 5 from the previous night, and was very constricted and on multiple pressers at high level. The indications for use were post-operative aortic and mitral valve replacement, tricuspid repair and maze procedure. There have been no additional alarms since the patient's chest was opened and augmentation was decreased. Iab therapy was able to be provided. There was water condensation in the drain port, but the customer was informed if there are no additional leak in iab circuit alarm 2-3 consecutive auto fill cycles will clear the condensation. Ventilator settings are night tidal volume and peep(positive end-expiratory pressure) of 7. The console was not exchanged and there were no further alarms.
 
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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 Key7526241
MDR Text Key109047409
Report Number2248146-2018-00346
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2021
Device Catalogue Number0684-00-0575
Device Lot Number3000067897
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2018
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: 05/18/2018 Patient Sequence Number: 1
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