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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8 FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8 FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problems Restricted Flow rate (1248); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2020
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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated catheter restriction and kink alarms after the patient was transferred in from another facility.The same alarm occurred again, but this time the customer could not clear it.The console was put into stand-by for at least 30 minutes, and the customer was then advised to remove the iab.There was no patient harm or adverse event reported.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated catheter restriction and kink alarms after the patient was transferred in from another facility.The same alarm occurred again, but this time the customer could not clear it.The console was put into stand-by for at least 30 minutes, and the customer was then advised to remove the iab.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with traces of blood on the exterior and between the catheter and the returned maquet sheath.The extender tubing was also returned.A catheter tubing/inner lumen kink was observed near the y-fitting at approximately 75.9cm from the iab tip.The inner lumen was found to be broken within a kink inside the membrane at approximately 26.9cm from the iab tip.Lastly, the extracorporeal tubing was returned cut in two pieces at approximately 14.7cm from the rear of the y-fitting.An underwater leak test of the balloon, y-fitting, catheter tubing, extracorporeal tubing and extender tubing was performed and a leak was detected at the inner lumen break location.The iab was placed on the cs300 pump for a complete autofill cycle.The iab did not pump and alarmed.The evaluation was unable to duplicate the reported restriction alarm.However, the kink found on the catheter tubing/inner lumen caused an autofill failure alarm.Additionally, kinks may also cause a restriction alarm.The evaluation confirmed the reported problem.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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint (b)(4).
 
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Brand Name
SENSATION PLUS 8 FR. 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10785906
MDR Text Key214582798
Report Number2248146-2020-00585
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108605
UDI-Public10607567108605
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 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/14/2023
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000121471
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Date Manufacturer Received12/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient Weight80
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