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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01U
Device Problems Device Displays Incorrect Message (2591); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 03/25/2022
Event Type  malfunction  
Event Description
Patient came to unit from the cardiac cath lab after placement of an intra-aortic balloon pump (iabp). Within 20 minutes of arrival to the unit, the pump started alarming "iab optical sensor failure. " troubleshooting included unplugging and replugging the orange fiber optic cable with no resolution of alarm. , was unable to get any pressure wave form or numbers for augmented pressure/assisted pressures, heart rate, etc. Switched out the actual balloon pump machine and fiber optic cable, helium tubing, bs ekg cables switched over to new pump. Same alarm of "iab optical sensor failure" continues. Called the perfusion tech on call who called the maquet representative. Troubleshooting phone call from representative included hooking up a manual arterial line pressure transducer to the machine to get a pressure waveform, as there were no waveforms on the screen other than ekg. Iabp started alarming "unable to update timing" after manual pressure cable was connected and zeroed. Iabp continues to alarm "unable to update timing every one minute or so. " pump turned to manual per doctor to diminish alarm problem. The next morning, the iabp was placed in semi-auto mode and it did not alarm at all in regards to "unable to update timing so the nurse left it in semi-auto mode. The manual pressure transducer was still connected. Iabp mean in the 80-90's, wave form shows late inflation due to iabp optical sensor failure. Cardiologist pulled back slightly on the catheter for possible kink in the line. Wave form looks slightly better. Determined the root cause that most likely it is an issue with a kinked/damaged fiber optic tip on the catheter itself. Patient underwent aortic to coronary bypass graft the next am. The catheter was removed one day post op. The catheter was saved after removal and will be returned to the manufacturer for inspection upon their request.
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law dr
fairfield NJ 07004
MDR Report Key14117487
MDR Text Key289338590
Report Number14117487
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/05/2022,03/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0576-01U
Device Catalogue Number0684-00-0576-01U
Device Lot NumberN/D
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2022
Event Location Hospital
Date Report to Manufacturer04/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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