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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CS300 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number CS300 INTRA-AORTIC BALLOON PUMP
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 07/25/2016
Event Type  Death  
Manufacturer Narrative
The company representative observed no blood in the purge line and observed excessive condensation in purge line. The company representative powered on unit without error. He verified blood back alarm in the fault log. Ran both moisture removal procedures. Verified calibration of blood back circuit, verified blood back alarm functionality and was unable to reproduce the ¿blood detected¿ alarm. The company representative ran operational test with patient simulator for three hours without issue. The iabp was tested to factory specification. It functioned normally and was returned to the customer. In addition the company representative placed a phone call with clinical support and several members of staff. Clinical support walked the customer staff through the moisture removal procedure to be utilized on a unit that is running on a patient and exhibiting high amounts of condensation.
 
Event Description
The customer reported that while the iabp was in use on a patient, the iabp generated a ¿blood back¿ alarm and stopped pumping. The iab treatment was suspended and no replacement unit was ordered. The patient was considered terminal by the physician, so no replacement unit was placed on the patient or treatment attempted to be continued. The patient coded 1 hour after treatment was suspended and coded again and died 5 hours after treatment was suspended. It¿s unknown if the patient death is attributed to the reported event.
 
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Brand NameCS300 INTRA-AORTIC BALLOON PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key5835089
MDR Text Key50805752
Report Number2249723-2016-00022
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCS300 INTRA-AORTIC BALLOON PUMP
Device Catalogue Number0998-00-3023-53
Other Device ID NumberSI184645K0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/29/2016 Patient Sequence Number: 1
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