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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
Model Number 0684-00-0576-01
Device Problems Leak/Splash (1354); Gas Leak (2946)
Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the customer had seen blood inside the helium tubing. The patient was stable. The customer was advised to disconnect the iab from the console and remove the iab from the patient. Upon follow up approximately 40 minutes later. The iab still had not been removed. The console was in standby. The customer was advised to disconnect the helium tubing and power down the console. The customer was advised again that the iab needed to be removed as soon as possible. There was no patient harm or adverse event reported.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key11768947
MDR Text Key248880315
Report Number2248146-2021-00283
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 Other,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000134412
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/04/2021 Patient Sequence Number: 1
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