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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Filling Problem (1233); Leak/Splash (1354); Difficult to Remove (1528); Obstruction of Flow (2423); Gas/Air Leak (2946)
Patient Problem Injury (2348)
Event Date 06/13/2019
Event Type  Injury  
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. Complaint record id # (b)(4). Device not returned.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the clinicians had noted a brownish fluid in the helium tubing but continued to pump with a second console. Pumping continued for at least five more hours when the iabp alarmed gas loss, autofill failure and catheter restriction causing the user to contact the cardiologist who took the patient to the cardiac cath lab and attempted to remove the balloon. The doctor was unable to remove it and the patient was taken to the cvor (cardiovascular operating room)to remove the iab.
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key8752754
MDR Text Key149781829
Report Number2248146-2019-00573
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 Biomedical Engineer
Type of Report Initial
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/25/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000092766
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/13/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/02/2019 Patient Sequence Number: 1
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