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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-XX
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 09/10/2016
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) for the iabp involved in the event was reviewed. There were no non-conformances in the dhr related to the reported event. The service representative observed fault code # 37 (autofill failure) and the reported "gas loss in iab circuit" alarm however was unable to duplicate the reported issue. Unrelated to the event, it was also reported that the service representative replaced the safety disk (part #: 0202-00-0140) that was past due for replacement per the preventive maintenance by factory specification. The iabp was tested to factory specification. It functioned normally and was returned to the customer. The manufacture evaluated the fault logs and concluded that the recorded alarms are consistent with iab catheter failures however it is not possible to evaluate the iab catheter because the customer discarded it. The manufacture also evaluated pictures of the solid white line/"white balk" and determined that is the time in standby area that will appear whenever the iabp has assisted and then has been put in standby either manually by the user or automatically by a high priority alarm as reported in the event description.
 
Event Description
The customer reported: patient was put on intra-aortic balloon pump (iabp) therapy due to weak heart circulation after having aorto-coronary bypass surgery and aortic valve replacement. During iabp therapy, the iabp generated an "air leakage" alarm ("gas loss in iab circuit"). Along with the alarm, a solid white line/"white balk" appeared on the display. The caregivers checked the iab with a syringe to make sure that was no blood or leaks inside the iab tubing. The caregivers also verified the iab position with x-ray and checked there were no blood clots by transesophageal echocardiography (tee). The patient¿s health status deteriorated and the caregivers made the decision to stop therapy. Shortly after the discontinuation of therapy, the patient died. The patient death per the caregivers, was not attributed to the iabp.
 
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Brand NameCARDIOSAVE
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 Key6015695
MDR Text Key56913567
Report Number2249723-2016-00030
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-0800-XX
Other Device ID NumberCA243285C4
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 Received09/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
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: 10/10/2016 Patient Sequence Number: 1
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