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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number D998-00-0800-53
Device Problems Circuit Failure (1089); No Display/Image (1183); No Device Output (1435); Programming Issue (3014)
Patient Problems Death (1802); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Occlusion (1984); Shock (2072)
Event Date 04/03/2014
Event Type  No Answer Provided  
Event Description
An elderly patient had hypertension (htn), a myocardial infarction (mi) and was in shock.The patient had major vessel occlusions and was catheterized and resuscitated, but required an intra-aortic balloon pump (iabp).The flight team was requested from our facility to pick the patient up at the outside facility and transport them back to our facility for extracorporeal membrane oxygenation (ecmo).The transport team arrived and attempted to switch the patient to the maquet cardiosave hybrid iabp.The team could not get an electrocardiogram (ekg) tracing on the iabp regardless of using alternate cables, connectors, etc., and therefore, were not able to transport the patient who required an inflight ekg tracing for balloon pump management.The patient ultimately was transported by another carrier by ambulance, coded en route and was returned to the sending hospital where she died.Manufacturer response: they could not duplicate the problem; however, they did determine that the unit displayed corrupt date and time on the log printout, and they replaced the executive processor board.
 
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Brand Name
CARDIOSAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfiled NJ 07004
MDR Report Key3885690
MDR Text Key15177857
Report Number3885690
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? *
Device Operator Nurse
Device Model NumberD998-00-0800-53
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2014
Event Location Hospital
Date Report to Manufacturer06/20/2014
Patient Sequence Number1
Treatment
OTHER; CARDIAC DRUGS; PACEMAKER, ZOLL MONITOR
Patient Age66 YR
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