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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problem Leak/Splash (1354)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/24/2022
Event Type  Death  
Manufacturer Narrative
Event site postal code: (b)(6). 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).
 
Event Description
It was reported that the patient had open cardiac surgery with cardiopulmonary bypass (cpb). The patient needed a double mitral-aortic valve replacement due to endocarditis. It was noted that weaning off cpb was difficult and high drug support was required in the operating room (or) and while on cpb. Intra-aortic balloon (iab) therapy was initiated to help support the weaning. After insertion, a treatment by ecmo was performed of second-line in addition to iab therapy. The patient was then transferred to the intensive care unit (icu). After approximately two days of iab therapy, a leak occurred and blood was seen in the tubing. It was also noted that the console had generated an alarm. The iab was removed and replaced with a new one to continue therapy. Despite the support, the patient expired due to their condition of endocarditis and double valve replacement. This report is for the 1st iab used in this event. A separate report will be submitted for the 2nd iab.
 
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Brand NameSENSATION 7FR. 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 Key13876184
MDR Text Key287770843
Report Number2248146-2022-00234
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106779
UDI-Public10607567106779
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000136078
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2020
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 03/24/2022 Patient Sequence Number: 1
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