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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problems Filling Problem (1233); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2019
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 while initiating intra-aortic balloon (iab) therapy, an autofill failure alarm occurred. Another iab was used to continue therapy. There was no reported patient injury.
 
Event Description
It was reported that while initiating intra-aortic balloon (iab) therapy, an autofill failure alarm occurred. Another iab was used to continue therapy. There was no reported patient injury.
 
Manufacturer Narrative
The product was returned with the membrane loosely folded and traces of blood on the exterior of the catheter. The extender tubing was also returned. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender 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 reported events cannot be confirmed by the evaluation. The product performed according to specification. 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. (b)(4).
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8483723
MDR Text Key141086895
Report Number2248146-2019-00272
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
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 05/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/15/2021
Device Catalogue Number0684-00-0605
Device Lot Number3000082758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received05/09/2019
Is This a Reprocessed and Reused Single-Use Device? No

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