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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 Problems Migration or Expulsion of Device (1395); Gas Leak (2946)
Patient Problem Urinary Retention (2119)
Event Date 11/02/2019
Event Type  Injury  
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 helium loss alarm. Connections were checked and were good. The patient was checked and was okay. No blood was noted inside of the balloon or in the tubing. Upon restarting the pump, the alarm for helium loss was noted again. Physician was notified and it was determined to remove the intra-aortic balloon catheter (iabc). The customer suspected that the catheter had migrated. Patient had decreased urine output but that does not explain the helium loss.
 
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Brand NameSENSATION PLUS 8FR. 50CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key9363839
MDR Text Key167787979
Report Number2248146-2019-00890
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/15/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000091787
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/22/2019 Patient Sequence Number: 1
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