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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0469-01
Device Problems Inability to Auto-Fill (1044); Gas Leak (2946)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  Injury  
Event Description
It was reported that after approximately three months of intra-aortic balloon (iab) therapy, the console generated auto-fill failure and gas loss alarms. The insertion was reported to be axillary, which is not the method described in the device instructions for use. It was noted that the patient's condition was deteriorating over the last day or two, prior to the alarms. Without iab therapy, the patient's condition continued to decline. The iab was later removed and replaced with a different manufacturer's device. There was no patient harm or adverse event reported.
 
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).
 
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Brand NameSENSATION 7FR. 34CC 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 Key12806257
MDR Text Key280777352
Report Number2248146-2021-00746
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0469-01
Device Catalogue Number0684-00-0433
Device Lot Number3000134799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/12/2021 Patient Sequence Number: 1
Treatment
CARDIOSAVE PUMP CH300432D9 IMPELLA
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