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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 Backflow (1064); Leak/Splash (1354); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2018
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 there was a "leak in iabp system" alarm noted.After several days of therapy, blood was visible in the balloon catheter.Catheter was removed.Another catheter was attempted to be insert but blood came back which was possibly channeling.The iab pump is intact.A third catheter was inserted successfully.This submission is for the 2nd iab used.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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy there was a "leak in iabp system" alarm noted.After several days of therapy, blood was visible in the balloon catheter.Catheter was removed.Another catheter was attempted to be insert but blood came back which was possibly channeling.The iab pump is intact.A third catheter was inserted successfully.This submission is for the 2nd iab used.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane loosely folded and blood found on the exterior of the catheter.The one-way valve was also returned.No blood was observed inside the iab catheter.The one-way valve was vacuum tested and it held vacuum.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete auto fill cycle.The iab pumped normally and no alarm sounded from the pump.The returned condition of the product indicates that the reported problem resulted from a condition known as ¿channeling¿.Arterial blood under pressure may run the length of the folds in the balloon membrane and drip or be expelled under arterial pressure from the balloon/catheter junction.This "channeling" is not a leak and will diminish as the iab catheter is inserted.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy there was a "leak in iabp system" alarm noted.After several days of therapy, blood was visible in the balloon catheter.Catheter was removed.Another catheter was attempted to be insert but blood came back which was possibly channeling.The iab pump is intact.A third catheter was inserted successfully.This submission is for the 2nd iab used.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
MDR Report Key7279909
MDR Text Key100544701
Report Number2248146-2018-00103
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/30/2020
Device Catalogue Number0684-00-0497
Device Lot Number3000052336
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2018
Device AgeYR
Date Manufacturer Received05/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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