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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Restricted Flow rate (1248)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2019
Event Type  malfunction  
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 record id # (b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, the console generated a check iab catheter alarm.The balloon was removed and replaced.There was no reported injury to the patient.
 
Manufacturer Narrative
Updated sections: a4, b4, g4, g7, h2, h3, h6, h10.The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.One kink was found on the catheter tubing near the y-fitting approximately 75.4cm from the iab tip.The optical fiber was found to broken at this location.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 autofill cycle.The iab pumped normally and no alarm sounded from the pump.The evaluation determined a kink in the catheter and optical fiber break.It is difficult to determine when or how a kink in the catheter and optical fiber break occurs.Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause inflation difficulty or an alarm.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint record # (b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, the console generated a check iab catheter alarm.The balloon was removed and replaced.There was no reported injury to the patient.
 
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Brand Name
SENSATION PLUS 8FR. 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9560030
MDR Text Key188207182
Report Number2248146-2020-00007
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/23/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000105002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received01/07/2020
Supplement Dates Manufacturer Received01/23/2020
Supplement Dates FDA Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
Patient Weight132
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