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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Material Rupture (1546)
Patient Problems Low Oxygen Saturation (2477); Confusion/ Disorientation (2553); Diminished Pulse Pressure (2606); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/09/2021
Event Type  malfunction  
Event Description
Registered nurse (rn) noted intra-aortic balloon pump was not augmenting or filling appropriately, contacted nurse practitioner (np) from cardiovascular intensive care unit (cvicu) who confirmed finding at bedside. Upon inspection of tubing, found blood indicating balloon rupture. Pressor requirements quickly escalated with mean arterial pressure 40-50 eventually requiring norepinephrine , neosynephrine and epinephrine. Additional providers notified and cardiologist, fellow and cardiovascular intensivist came to bedside to exchange balloon and pump. Patient experienced oxygen desaturation during procedure and disorientation requiring intubation and ventricular tachycardia requiring cardioversion that return to rhythm; however patient was pulseless electrical activity (pea) as there was no palpable pulse. Cardiopulmonary resuscitation (cpr) began, code team called and return of spontaneous circulation (rosc) achieved. Unfortunately balloon was not saved; however pump and tubing connected to balloon were and turned over to biomed.
 
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Brand NameCARDIOSAVE HYBRID, TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key12727375
MDR Text Key279333067
Report Number12727375
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 Risk Manager
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot Number3000141070
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2021
Event Location Hospital
Date Report to Manufacturer11/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/01/2021 Patient Sequence Number: 1
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