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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0433
Device Problems Kinked (1339); Occlusion Within Device (1423); Pumping Stopped (1503); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2018
Event Type  malfunction  
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. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the iab pump (iabp) stopped pumping while in use on a patient and a "restriction in iab circuit" alarm was generated. The catheter was noted to have a large amount of clear fluid. A getinge field service engineer (fse) went to the customer site to the service the iabp and stated the iabp stopped pumping during use. The fse found the iab to be kinked as well as clotted. The fse performed all functional and electrical safety tests on the iabp and no problem was found. The iabp passed all tests and is cleared for clinical use. There was no reported injury to the patient. The date of the event is unknown.
 
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Brand NameSENSATION 7FR. 34CC 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 Key7471664
MDR Text Key106979476
Report Number2248146-2018-00290
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
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 06/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/16/2020
Device Catalogue Number0684-00-0433
Device Lot Number30000563110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received05/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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