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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problems Off-Label Use (1494); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2021
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 record id # (b)(4).
 
Event Description
It was reported that after a couple days of intra-aortic balloon (iab) therapy, the console was generating an iab catheter restriction alarm as the patient was brought to the operating room for a left ventricular assist device (lvad) placement.The surgeon commented that they would remove the iab the following morning.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer was made aware of the off-label use and advised they would continue to troubleshoot as if it were a femoral insertion.At this point, the console had been in stand-by mode for 22 minutes.After some quick discussion of troubleshooting, the customer was able to restart the therapy.The customer stated that they had repositioned the patient to relieve the kink.They verbalized that there was no visual blood, no kinks, no condensation in the helium tubing, and all connections were secure.There was no patient harm, or adverse event reported.
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).
 
Event Description
N/a.
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
MDR Report Key12420993
MDR Text Key269816251
Report Number2248146-2021-00568
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 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/05/2024
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000143119
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/28/2021
Patient Sequence Number1
Treatment
CARDIOSAVELEFT VENTRICULAR ASSIST DEVICE (LVAD).; CARDIOSAVELEFT VENTRICULAR ASSIST DEVICE (LVAD)
Patient Age35 YR
Patient Weight79
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