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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Pumping Stopped (1503); Output Problem (3005); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and found that the unit had no initial start-up errors. The fse could not duplicate any initial shutdown failure during pre-testing. The fse checked the fault/error logs and noted codes 111 and 112 were present. To address the logged errors, the fse opted to replace the executive processor board. Full calibration and functional checkout were performed, and the iabp unit was rolled around while under simulation. The error logs were checked once again and no further issues were found. The iabp unit was then cleared for clinical use. (b)(6).
 
Event Description
It was reported that while a patient was receiving therapy on a cardiosave intra-aortic balloon pump (iabp) on 1:1 observation, an alarm sounded, pumping stopped and the screen froze. The user could not "reiniate" pumping on the iabp by pressing the start button; and cardiopulmonary bypass was initiated immediately, as the patient was heparinized and cannulated. The iabp unit was turned off and then back on, and no alarms occurred. The gas pressure tracing was leveled, about mid balloon and no blood was noted in the balloon catheter connector. The unit was then turned off and switched out with another cardiosave unit, which started uneventfully with no alarms. The faulty unit was removed from service and taken to the bioengineering department. At this time, there is no information that the alleged malfunction caused or contributed to any change in the patient's condition that would be considered a reportable serious injury.
 
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Brand NameCARDIOSAVE HYBRID
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 Key8035024
MDR Text Key126532790
Report Number2249723-2018-01904
Device Sequence Number0
Product Code DSP
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
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 Received10/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2017
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: 11/02/2018 Patient Sequence Number: 1
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