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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0497
Device Problems Obstruction of Flow (2423); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2017
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.Complaint # (b)(4).
 
Event Description
It was reported that on the morning of (b)(6) 2017, at 0700hrs, slow gas alarm noted.Staff member silenced alarm and checked patient.Noted blood in extender tubing.Ceased counterpulsation intra-aortic balloon (iab) therapy.Catheter disconnected from console, though blood noted in extender tubing at safety disk of iab pump.Catheter removed from patient by intensivist.There was no reported injury to the patient.
 
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint # (b)(4).
 
Event Description
It was reported that on the morning of (b)(6) 2017, at 0700hrs, slow gas alarm noted.Staff member silenced alarm and checked patient.Noted blood in extender tubing.Ceased counterpulsation intra-aortic balloon (iab) therapy.Catheter disconnected from console, though blood noted in extender tubing at safety disk of iab pump.Catheter removed from patient by intensivist.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior of the catheter.The male luer from extracorporeal tubing was cut and returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1.3cm from the rear seal measuring 0.03cm in length.The evaluation confirmed the reported leak, blood in tubing & slow gas alarm problem.The reported slow gas alarm and blood in tubing was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by contact with calcified plaque in the aorta.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4).
 
Event Description
It was reported that on the morning of (b)(6) 2017, at 0700hrs, slow gas alarm noted.Staff member silenced alarm and checked patient.Noted blood in extender tubing.Ceased counterpulsation intra-aortic balloon (iab) therapy.Catheter disconnected from console, though blood noted in extender tubing at safety disk of iab pump.Catheter removed from patient by intensivist.There was no reported injury to the patient.
 
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Brand Name
MEGA 8FR. 50CC IAB
Type of Device
SYSTEM, 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 Key7031180
MDR Text Key93034032
Report Number2248146-2017-00642
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/10/2020
Device Catalogue Number0684-00-0497
Device Lot Number3000047057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2018
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received02/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age84 YR
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